[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Mental Health Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":621},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,41,72,94,110,140,163,194,217,239,261,290,319,348,377,404,426,443,464,486,505,535,558,576,595],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652725","home-based-wearable-rtms-therapy-for-moderate-to-severe-depression-100652725",false,"NCT07775586","Home-Based Wearable rTMS Therapy for Moderate to Severe Depression","Multicenter Randomized Controlled Trial Assessing Wearable Repetitive Transcranial Magnetic Stimulation for Home-Based Treatment of Depression","1\\. Inclusion Criteria\n\n1. Demographics Aged 18-65 years, any gender. Minimum education: primary school completion (≥6 years of formal education).\n2. Diagnostic and Severity Requirements Meet DSM-5 criteria for Major Depressive Disorder (MDD). Current moderate-to-severe depressive episode, defined by Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥18 .\n3. Pharmacological Stability Stable antidepressant regimen for ≥4 weeks prior to enrollment, restricted to SSRIs (Selective Serotonin Reuptake Inhibitors).\n\n   Treatment-naïve patients permitted if no psychotropic medications used within the prior 4 weeks.\n\n   Mandatory maintenance of the same regimen throughout the study and post-treatment follow-up.\n4. Technical Feasibility Medically eligible for both structural MRI and resting-state functional MRI (fMRI) examinations.\n\n2\\. Exclusion Criteria\n\n1. Psychiatric Comorbidities Any concurrent psychiatric diagnosis (e.g., autism spectrum disorder, severe cognitive impairment, epilepsy, mania, psychosis) .\n2. Neurological Structural Abnormalities Structural brain lesions increasing seizure risk or disrupting neural connectivity (e.g., brain tumors, history of stroke).\n3. Systemic Medical Conditions Unstable cardiovascular, respiratory, hepatic, renal diseases, or active malignancies.\n4. Contraindications to Procedures TMS contraindications: Metallic implants, pacemakers, history of epilepsy. MRI contraindications: Ferromagnetic implants, claustrophobia requiring sedation.\n5. Recent Neuromodulation Therapies Prior ECT (Electroconvulsive Therapy) or rTMS (repetitive Transcranial Magnetic Stimulation) within 3 months.\n\nHistory of neurosurgical interventions for depression (e.g., deep brain stimulation).\n\n6）Special Populations Pregnancy, lactation, or planning pregnancy during the study. 7）Medication Instability Planned adjustments to pharmacotherapy during the study period. 3. Withdrawal and Discontinuation Criteria\n\n1. Participant-Initiated Withdrawal Voluntary withdrawal: Participant withdraws consent (e.g., refusal to risk assignment to sham stimulation group).\n2. Investigator-Initiated Withdrawal Non-compliance with inclusion criteria: Post-randomization discovery of ineligibility (e.g., symptom remission, medication non-adherence).\n\n   Serious Adverse Events (SAEs):\n\n   TMS-related SAEs (e.g., seizure, intractable headache, exacerbated suicidality).\n3. Study Discontinuation\n\nPrespecified Efficacy Stoppage:\n\nInterim analysis at n=30\u002Fgroup showing superiority of active intervention (Cohen's d \\>0.8) .\n\nSafety-Driven Discontinuation:\n\nUnacceptable risk profile (e.g., recurrent SAEs such as seizures or suicidality).\n\nLoss to Follow-Up:\n\nTrial termination if attrition rate exceeds pre-specified thresholds compromising statistical power (e.g., \\>20% dropout).","ALL","18 Years","65 Years",{"count":21,"type":22},124,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background and Rationale\n\nWith rapid economic development and increasing societal pressures, the incidence of neuropsychiatric disorders has risen annually, ranking as the leading cause of disability worldwide and imposing a severe societal burden. Among these, depressive disorders represent a primary contributor. However, the efficacy and accessibility of transcranial magnetic stimulation (TMS) for depression face significant challenges. Key limitations include:\n\nLow targeting accuracy with traditional localization methods. Limited clinical penetration of individualized precision paradigms .\n\nIn this context, wearable repetitive TMS (wrTMS) technology offers a transformative solution. The rTMS-Tiny device, developed by the Institute of Automation, Chinese Academy of Sciences, exemplifies this innovation with the following features:\n\nBattery-powered with a pulse capacity exceeding 8,000 pulses per charge. Ultra-lightweight design: Total system weight \\\u003C3 kg, coil helmet \\\u003C2 kg (10% of conventional devices).\n\nPerformance parity: Comparable efficacy to standard rTMS systems while enabling protocols like Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) .\n\nAdvantages of rTMS-Tiny Portable Design and Wearable Application Ergonomically optimized helmet allows near-unrestricted daily activities during treatment .\n\nStreamlined Operational Workflow Simplified protocols significantly reduce clinician workload . Enhanced Treatment Tolerability Improved comfort increases treatment completion rates and long-term adherence, directly enhancing therapeutic outcomes .\n\nThese advantages enable high-dose, intensive regimens (e.g., SAINT-like protocols) in routine clinical practice .\n\nScientific Imperative for a Multicenter RCT\n\nA multicenter randomized controlled trial (RCT) of rTMS-Tiny is clinically and scientifically warranted to:\n\nTest two core hypotheses:\n\nHypothesis 1: Efficacy of rTMS-Tiny in reducing depressive symptoms. Hypothesis 2: Safety of home-based rTMS-Tiny administration . Generate high-level evidence to advance neuromodulation into an era of precision, personalization, and artificial intelligence-driven therapy .",[28],"Major Depressive Disorder","NOT_YET_RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":32,"type":22},{"date":36,"type":22},"2028-06-30",{"name":38,"class":39},"Shanghai Mental Health Center","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":40},"100524694","efficacy-and-safety-of-combo-stim-deep-brain-stimulation-for-treatment-refractory-mental-disorders-100524694","NCT06112067","Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders","Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders: a Multi-center, Single Arm, Prospective, Open-label, Extendable Study","Inclusion Criteria:\n\n1. Treatment refractory obsessive-compulsive disorder:\n\n   1. Aged 18\\~65 when signing informed consent, outpatient or inpatient, male or female.\n   2. Fits DSM-5 obsessive-compulsive disorder criteria.\n   3. Fits treatment refractory obsessive-compulsive disorder criteria (both i and ii):\n\n   i.Treated with at least 3 kinds of serotonin reuptake inhibitors (SSRIs) with at least 2 kinds of 2nd generation antipsychotic medication as enhancement, enough dosage and enough course of treatment, and still no effect or intolerant.\n\n   ii.While using enough dosage of SSRIs, treated with more than 8\\~12 times of Cognitive Behavior Therapy (CBT) or CBT-intolerant.\n\n   d)Y-BOCS score ≥ 25 in screening period and baseline. e)CGI-S score ≥ 4 in screening period and baseline. f)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.\n2. Treatment refractory schizophrenia:\n\n   1. Aged 18\\~65 when signing informed consent, outpatient or inpatient, male or female.\n   2. Fits DSM-5 schizophrenia criteria.\n   3. Course of disorder ≥ 5 years.\n   4. Fits treatment refractory schizophrenia criteria, one of the conditions below:\n\n   i.Treated with more than 2 different anti-psychotic medications (clozapine excluded), enough dosage (equivalent dosage as chlorpromazine ≥ 600mg\u002Fday), enough course of treatment (≥ 12 weeks), no effect or intolerant.\n\n   ii.Treated with enough dosage of clozapine (≥ 300mg\u002Fday or blood medication concentration ≥ 350ng\u002Fml, enough course of treatment (≥ 12 weeks), no effect or intolerant.\n\n   e)PANSS score ≥ 70 in screening period and baseline, and at least 1 item from 5 items (P1, P2, P3, P5, P6) of PANSS positive symptom scale ≥ 4; or at least 3 items from PANSS negative symptom scale (N1\\~N7) ≥ 4, or at least 2 items ≥ 5.\n\n   f)CGI-S ≥ 4 in screening period and baseline. g)GAF ≤ 60 in screening period and baseline. h)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.\n3. Treatment refractory bipolar with depression:\n\n   1. Aged 18\\~65 when signing informed consent, outpatient or inpatient, male or female.\n   2. Fits DSM-5 bipolar I or bipolar II criteria, currently with depression episode.\n   3. Course of disorder ≥ 2 years.\n   4. Fits treatment refractory bipolar with depression criteria (treated with two different kinds of treatment below, enough dosage and enough course of treatment ≥ 8 weeks, and cannot acquire symptom cure for 8 consecutive weeks, either i or ii):\n\n   i.Used at least two medications (alone) among Olanzapine (10-20mg\u002Fd) + Fluoxetine (20-60mg\u002Fd), Quetiapine (200-600mg\u002Fd), Lurasidone (40-160mg\u002Fd), Lamotrigine (200-400mg\u002Fd) ii.Used at least one medication above (alone), and used one of medication above with another medication among Lamotrigine (200-400mg\u002Fd), Valproate (1000-2000mg\u002Fd) and lithium salt (blood lithium reaches 0.8mmol\u002FL).\n\n   e)Upon medication treatment, electroconvulsive therapy ≥ 12 times, no effect or failed (such as intolerant).\n\n   f)Fits severe symptom criteria: i.Depression episode ≥ 12 weeks in screening period. ii.MADRS score ≥ 26 in screening period and baseline. iii.GCI-BP score ≥ 4 in screening period and baseline. iv.YMRS score ≥ 12 in screening period and baseline. g)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.\n4. Treatment refractory anorexia nervosa:\n\n   1. Aged 18\\~65 when signing informed consent, outpatient or inpatient, male or female.\n   2. Fits DSM-5 anorexia nervosa criteria, consider both restricting type and binge-eating\u002Fpurging type.\n   3. 10 ≤ BMI \\\u003C 16 in screening period and baseline.\n   4. Fits treatment refractory anorexia nervosa criteria (both i, ii, iii and iv):\n\n   i.Course of disorder ≥ 5 years, severe and sustained anorexia nervosa. ii.With ≥ 3 times repeated inpatient history and bad treatment effect (can't complete treatment or immediate relapse after treatment).\n\n   iii.Through systemic nutrient treatment, medication (SSRIs and\u002For anti-psychotics), psychotherapies (such as reinforced CBT, FBT treatment), no effect or intolerant.\n\n   iv.Worsened instability of clinical treatment, refuse treatment or bad reaction to reinforced treatment, last for more than 1 year, with more than 2 times of involuntary food intake.\n\n   e)Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.\n5. Gambling disorder:\n\n   1. Aged 18\\~65 when signing informed consent, outpatient or inpatient, male or female.\n   2. Course of disorder ≥ 2 years.\n   3. Diagnosed as gambling disorder based on DSM-5, fits medium or severe diagnostic standard (≥ 6 terms)\n   4. Received systemic treatment (such as medication and social mental intervention) but still has iterative thoughts of impulse or gambling behaviors.\n   5. Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.\n6. Adult autism:\n\n   1. Aged 18\\~65 when signing informed consent, outpatient or inpatient, male or female.\n   2. Fits DSM-5 autism spectrum disorder diagnostic standard, and there's severe, life-threatening iterative behaviors, and independently evaluated by two psychiatric doctors.\n   3. AuBC score ≥ 62 in screening period and baseline.\n   4. CGI-S score ≥ 4 in screening period and baseline.\n   5. Course of disorder ≥ 10 years, received systemic behavior intervention or training ( such as critical reaction training, cognitive behavior intervention, language expression training, demonstration method, natural environment training, patriarch training, social skill training, intervention based on story tales, etc. ) but failed, or intolerant.\n   6. Patient and guardian agree to DBS implant and sign informed consent after fully understood research aims, contents, anticipated treatments and risks.\n\nExclusion Criteria:\n\n1. With mental disorders including physical mental disorders, paranoid personality disorder, delayed mental development etc.\n2. Through clinical evaluation by investigators, there exists significant suicide behavior risk.\n3. From screening period to baseline, patients who has significant improvement in evaluation scores:\n\n   1. Obsessive compulsive disorder: Y-BOCS score decreased (or improved) ≥ 20%\n   2. Schizophrenia: PANSS score decreased (or improved) ≥ 20%\n   3. Bipolar with depression: MADRS score decreased (or improved) ≥ 20%\n   4. Anorexia nervosa: BMI improved ≥ 20%\n   5. Gambling: through evaluation by investigators, online gambling behavior is significantly improved\n   6. Adult autism: AuBC score decreased (or improved) ≥ 20%.\n4. With severe or unstable cardiovascular, inspiratory, liver, kidney, blood, endocrine, neural system or other system disorders.\n5. Has neural system disorders including physical brain disorders, brain trauma, treatment-refractory seizure etc.\n6. During screening period or baseline, abnormalities in patient's physical examination, laboratory examination, electrocardiogram examination, imaging examination have significant clinical meaning, and patients who are considered unfit by investigators.\n7. Implanted artificial cochlea, pacemaker, similar single-side or double-side products or experienced other physical surgeries within half a year that are considered to have effect on this trial by investigators.\n8. DBS implant surgery taboos present and is considered unfit by investigators.\n9. Diagnosed as HIV positive.\n10. Female in gestation, lactation, or blood HCG \u002F urine gestation test positive. Or patients who can't take effective contraception actions during the trial. Or patients planning to birth or give birth after the trial begins for 3 months.\n11. Currently involved or involved in other medication or medical device clinical trials 3 months before the screening period.\n12. Other patients who are considered unfit by investigators.",{"count":49,"type":22},18,[25],"This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of combo-stim deep brain stimulation for treatment-refractory mental disorders (obsessive-compulsive disorder, schizophrenia, bipolar with depression, anorexia nervosa, gambling disorder and adult autism).",[53],"Deep Brain Stimulation",[55,56,57,58,59,60,61,62,63],"deep brain stimulation","nucleus accumbens","anterior limb of internal capsule","obsessive-compulsive disorder","schizophrenia","bipolar with depression","anorexia nervosa","gambling disorder","adult autism","RECRUITING","2026-08-18",{"date":32,"type":33},{"date":68,"type":33},"2023-10-16",{"date":70,"type":22},"2026-12",{"name":38,"class":39},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":93,"locationsCount":40},"100652678","closed-loop-tbs-targeting-rpo-for-the-core-clinical-features-of-the-methamphetamine-use-disorder-100652678","NCT07775807","Closed-loop TBS Targeting rPO for the Core Clinical Features of the Methamphetamine Use Disorder","A Pilot Single-Arm Study of Closed-Loop TBS Theta-Burst Stimulation Targeting the Right Parietal-Occipital Cortex for Core Clinical Features of Methamphetamine Use Disorder","Inclusion Criteria:\n\n* Aged 18 years old or older, ....with at least 9 years of education (junior high school or above) or able to fully understand the task.\n* Meets DSM-5 for mild\u002Fsevere amphetamine-type substance use disorder.\n* History of amphetamine-type substance use for no less than 1 year, with use at least once per week.\n* Has not received pharmacological treatment for substance use.\n\nExclusion Criteria:\n\n* Presence of any organic disease, or diagnosis of any other psychiatric disorder according to DSM-5 (e.g., bipolar disorder, major depression disorder).\n* Contraindications to TMS, as assessed by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS).\n* Inability to complete assessments, treatment procedures, or follow-up due to cognitive or behavioral limitations.",{"count":80,"type":22},5,[25],"The goal of this clinical trial is to evaluate whether closed-loop theta-burst stimulation (TBS) targeting the right parietal-occipital cortex (rPO) can improve core clinical symptoms in individuals with methamphetamine use disorder (MUD), such as cue-reactivity and impaired inhibitory control.\n\nThe main questions it aims to answer are:\n\nCan closed-loop rPO-TBS significantly reduce cue-reactivity, as measured by a Visual Analog Scale (VAS) and a cue-reactivity task? Does closed-loop stimulation enhance cognitive control, assessed by performance on the Stop Signal Task (SST)?\n\nResearchers will administer closed loop TBS to determine whether it can improve the core symptoms of MUD.\n\nParticipants will:\n\nComplete a single closed-loop sessions. Receive theta-burst stimulation targeting the right parietal-occipital cortex while complete the cue-reactivity task.\n\nUndergo cue-reactivity assessment using a Visual Analog Scale (VAS) and complete the Stop Signal Task (SST) before and after the stimulation session.",[84,85,86,87],"Methamphetamine Use Disorder","Substance Use Disorder","Cue-reactivity","Craving","2026-08-16",{"date":32,"type":33},{"date":91,"type":22},"2026-08",{"date":70,"type":22},{"name":38,"class":39},{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":109,"locationsCount":40},"100604795","trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-100604795","NCT07154160","Closed-loop TMS for the Core Clinical Features of the Methamphetamine Use Disorder","A Single-blind, Randomized, Parallel Study of Closed-loop, Conventional and Random TMS for Core Clinical Features of Methamphetamine Use Disorder.","Inclusion Criteria:\n\nAged 18 years old or older, ....with at least 9 years of education (junior high school or above) or able to fully understand the task.\n\nMeets DSM-5 for mild\u002Fsevere amphetamine-type substance use disorder. History of amphetamine-type substance use for no less than 1 year, with use at least once per week.\n\nHas not received pharmacological treatment for substance use.\n\nExclusion Criteria:\n\nPresence of any organic disease, or diagnosis of any other psychiatric disorder according to DSM-5 (e.g., bipolar disorder, major depression disorder).\n\nContraindications to TMS, as assessed by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS).\n\nInability to complete assessments, treatment procedures, or follow-up due to cognitive or behavioral limitations.",{"count":102,"type":22},21,[25],"The goal of this clinical trial is to evaluate whether closed-loop transcranial magnetic stimulation (TMS) can improve core clinical symptoms in individuals with methamphetamine use disorder (MUD), such as cue-reactivity and impaired inhibitory control.\n\nThe main questions it aims to answer are:\n\nCan closed-loop TMS significantly reduce cue-reactivity, as measured by a Visual Analog Scale (VAS) and cue-reactivity task, compared to a conventional treatment protocol and random TMS ? Does closed-loop stimulation enhance cognitive control, assessed by performance on the Stop Signal Task (SST), more effectively than the other stimulation modes? Researchers will compare closed-loop, conventional, and random TMS conditions to determine whether closed-loop yields superior symptom improvement.\n\nParticipants will:\n\nBe randomly assigned to one of the three stimulation group (closed-loop, conventional and random) according to a pre generated random number table, and receive the corresponding stimulation session.\n\nUndergo cue-reactivity assessment using VAS and cue-reactivity task, and complete the SST before and after each stimulation session.",[84,85,86,87],{"date":30,"type":33},{"date":91,"type":22},{"date":70,"type":22},{"name":38,"class":39},{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":40},"100651933","phase-1-xingqi-daozhi-decoction-for-antipsychotic-induced-constipation-100651933","NCT07767526","Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation","A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial of Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation With Qi Stagnation Pattern","XQD-AIC","Inclusion Criteria:\n\nMeets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia.\n\nPositive and Negative Syndrome Scale (PANSS) total score ≤95, with a PANSS negative symptom subscale score ≤28.\n\nMeets the Rome IV diagnostic criteria for functional constipation with a qi stagnation pattern.\n\nAged 18 to 65 years. Has at least a junior high school education and is able to complete self-report questionnaires.\n\nHas not used other medications known to cause constipation within the past 3 months.\n\nHas had no history of constipation within the past 2 years and no previous gastrointestinal disease.\n\nDeveloped constipation after initiation of antipsychotic medication.\n\nExclusion Criteria:\n\nMeets DSM-5 diagnostic criteria for any psychiatric disorder other than schizophrenia.\n\nIs unable to maintain a normal diet because of psychiatric symptoms, or requires a special diet such as a diabetic diet, soft diet, liquid diet, fasting, or restriction of oral intake due to individual clinical circumstances.\n\nUses other medications that may cause or aggravate constipation. Has had constipation within the past 2 years or has a history of gastrointestinal disease.\n\nHas lactose intolerance. Has clinically significant medical conditions, including diabetes mellitus, hypothyroidism, connective tissue disease, or other significant physical illnesses.\n\nIs pregnant, planning pregnancy in the near future, or breastfeeding.",{"count":119,"type":22},46,[121,122],"PHASE1","PHASE2","Antipsychotic medications are widely used to treat schizophrenia but may cause constipation, which can lead to abdominal discomfort, reduced quality of life, and poor treatment adherence. Xingqi Daozhi Decoction is a traditional Chinese medicine formula used to relieve constipation associated with qi stagnation. This study aims to evaluate the effectiveness and safety of Xingqi Daozhi Decoction for antipsychotic-induced constipation with a qi stagnation pattern.\n\nThis is a single-center, randomized, double-blind, placebo-controlled exploratory study. A total of 46 participants with schizophrenia who developed constipation after taking antipsychotic medications will be enrolled. Participants will be randomly assigned to receive either Xingqi Daozhi Decoction granules or matching placebo granules twice daily for 8 weeks. Neither the participants nor the treating clinicians and outcome assessors will know the treatment assignment during the study.\n\nParticipants will be evaluated regularly during treatment. The study will assess changes in bowel movements, constipation symptoms, constipation-related quality of life, and treatment safety. Participants will also undergo routine clinical and laboratory safety assessments, and adverse events will be recorded throughout the study. The primary outcome focuses on the proportion of participants who achieve an improvement in complete spontaneous bowel movements during treatment.",[125,126],"Schizophrenia","Antipsychotic Drug",[125,128,129,130,131],"Xingqi Daozhi Decoction","Constipation","Antipsychotic drug","Traditional Chinese Medicine","2026-08-12",{"date":134,"type":33},"2026-08-17",{"date":136,"type":22},"2026-10-01",{"date":138,"type":22},"2028-12-31",{"name":38,"class":39},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":148,"targetDuration":150,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":40},"100651711","multimodal-cohort-study-of-generalized-anxiety-disorder-100651711","NCT07764211","Multimodal Cohort Study of Generalized Anxiety Disorder","A Cohort Study of Generalized Anxiety Disorder Based on Multimodal Data","MC-GAD","Inclusion Criteria:\n\nMeets the ICD-10 diagnostic criteria for generalized anxiety disorder (GAD). Aged 18 to 65 years. Hamilton Anxiety Rating Scale (HAMA) total score \\>14. Has at least a junior high school education and is able to complete self-report questionnaires.\n\nVoluntarily agrees to participate in the study and provides written informed consent.\n\nExclusion Criteria:\n\nMeets ICD-10 diagnostic criteria for any psychiatric disorder other than GAD, as assessed using the Mini International Neuropsychiatric Interview (M.I.N.I.).\n\nHas significant suicidal ideation or is considered to be at high risk of suicide.\n\nHas a clinically significant medical condition or clinically significant laboratory abnormalities.",{"count":149,"type":22},400,"1 Year","OBSERVATIONAL","Generalized anxiety disorder (GAD) is a common mental health condition characterized by persistent and excessive worry that is difficult to control. It can affect sleep, daily functioning, work, and quality of life. Some individuals experience long-lasting or recurrent symptoms, but the factors that influence the course and outcome of GAD are still not fully understood.\n\nThe main purpose of this study is to establish a long-term cohort of people with GAD and to better understand how their symptoms and health change over time. The study will also explore factors that may help predict symptom improvement, recurrence, and treatment outcomes.\n\nApproximately 400 adults with GAD who receive care at Shanghai Mental Health Center will participate in this study. Participants will undergo regular clinical assessments and follow-up visits.\n\nDuring the study, researchers will collect information about participants' symptoms, medical and treatment history, blood samples, and brain-related measurements. Participants will be followed at several time points to observe changes in symptoms and health. The information collected will be used to better understand the course of GAD and to support the development of more individualized approaches to diagnosis, treatment, and long-term care.",[154],"Generalized Anxiety Disorder (GAD)","2026-08-09",{"date":157,"type":33},"2026-08-13",{"date":159,"type":22},"2026-08-01",{"date":161,"type":22},"2030-12-31",{"name":38,"class":39},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":175,"studyType":151,"phases":4,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":193,"locationsCount":40},"100650258","tracking-risk-in-adolescents-and-children-for-early-identification-of-common-mental-disorders-100650258","NCT07744490","Tracking Risk in Adolescents and Children for Early Identification of Common Mental Disorders","A Longitudinal Study for Risk Identification of Common Mental Disorders in High-Risk Children and Adolescents","TRACE","Inclusion Criteria:\n\n1. Aged 7-17 years at enrollment.\n2. Meeting at least one of the following conditions: Having at least one first-degree relative with a depressive disorder, anxiety disorder, or obsessive-compulsive disorder; or exhibiting clinically relevant but subthreshold depressive, anxiety, obsessive-compulsive, or repetitive behavioral symptoms.\n3. Not meeting the full diagnostic criteria for a depressive disorder, anxiety disorder, or obsessive-compulsive disorder at baseline, as assessed using the K-SADS-PL.\n4. Willing and able to participate in the scheduled assessments and follow-up visits.\n5. Written informed consent provided by a parent or legal guardian and assent provided by the participant\n\nExclusion Criteria:\n\n1. A current or previous diagnosis of a depressive disorder, anxiety disorder, or obsessive-compulsive disorder.\n2. A severe psychiatric condition requiring immediate clinical intervention, including acute suicide risk, a psychotic disorder, or a bipolar disorder.\n3. A major neurological disorder, severe head injury, or serious or unstable medical condition that may interfere with study participation.\n4. Intellectual or cognitive impairment that prevents the participant from understanding or completing the study assessments.\n5. Inability or unwillingness of the participant or legal guardian to comply with the study procedures.","7 Years","17 Years",{"count":174,"type":22},200,"2 Years","This prospective observational cohort study will enroll approximately 200 children and adolescents aged 7-17 years who are at elevated risk for common mental disorders, including depressive disorders, anxiety disorders, and obsessive-compulsive disorder, based on family history or subthreshold emotional or behavioral symptoms. Participants will be followed for two years. Clinical assessments, questionnaires, EEG, biological samples, and MRI will be collected at scheduled intervals. The study aims to identify factors associated with the onset and progression of these disorders and support early risk identification.",[178,179,180,181],"High Risk","Depression \u002F Major Depressive Disorder","Anxiety Disease","Obsessive - Compulsive Disorder",[183,184,185,186],"children and adolescence","pediatric","high risk","mental disease","2026-07-30",{"date":189,"type":33},"2026-08-04",{"date":191,"type":22},"2026-07-25",{"date":161,"type":22},{"name":38,"class":39},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":202,"sex":17,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":150,"studyType":151,"phases":4,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":40},"100649449","imore-study-a-multi-omics-cohort-study-of-major-depressive-disorder-100649449","NCT07735143","iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder","iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling","iMORE+","Inclusion Criteria:\n\nGeneral criteria:\n\n* Participants aged 14-45 years.\n* Participants are able to understand the study procedures and provide written informed consent. For participants younger than 18 years, both the participant and their legal guardian must provide consent.\n\nMajor Depressive Disorder (MDD) cohort:\n\n* Meet DSM-5 criteria for major depressive disorder (single or recurrent episode).\n* Have a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥24 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥18.\n\nHealthy Control (HC) cohort:\n\n\\- Healthy participants without a current or lifetime diagnosis of major psychiatric disorders.\n\nExclusion Criteria:\n\nFor all participants:\n\n\\- Severe or unstable medical conditions, pregnancy or breastfeeding, or other conditions considered unsuitable for study participation.\n\nFor the MDD cohort:\n\n* Current or lifetime diagnosis of other major psychiatric disorders, including schizophrenia spectrum disorders, schizoaffective disorder, or bipolar disorder.\n* Substance use disorder within 12 months prior to screening.\n* Depression secondary to medical or neurological conditions.\n* Regular antidepressant treatment within 2 weeks prior to enrollment.\n* Electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagus nerve stimulation (VNS), or immunosuppressive therapy during the current depressive episode.\n* Current active suicidal plan or recent suicidal behavior considered unsuitable for participation.\n\nFor the HC cohort:\n\n* Current or lifetime diagnosis of any psychiatric disorder.\n* Significant depressive, anxiety, manic, or psychotic symptoms.\n* Previous treatment with antidepressants, antipsychotics, or mood stabilizers.\n* Significant family history of major psychiatric disorders.",true,"14 Years","45 Years",{"count":206,"type":22},150,"Major depressive disorder (MDD) is a common mental health condition characterized by substantial clinical heterogeneity and variability in treatment response. Current diagnosis and treatment selection for MDD mainly rely on clinical assessments, and reliable biological markers that can support diagnosis, predict antidepressant treatment response, guide personalized treatment, and improve understanding of disease mechanisms remain limited.\n\nThe goal of this prospective observational cohort study is to develop and optimize multi-omics-based models for MDD diagnosis and antidepressant treatment response prediction using longitudinal clinical characteristics and biological data collected from an independent prospective cohort. The study also aims to evaluate the generalizability and predictive performance of existing multi-omics-based models in this independent cohort of participants aged 14-45 years.\n\nThe main questions it aims to answer are:\n\nCan integrated clinical and multi-omics features identify biomarkers and develop predictive models for MDD diagnosis and antidepressant treatment response? Can existing multi-omics-based models for MDD diagnosis and treatment response prediction be replicated and validated in an independent prospective cohort?\n\nParticipants with MDD and healthy controls will undergo standardized clinical assessments, longitudinal follow-up, and biological sample collection for multi-omics profiling. Clinical and multi-omics data will be integrated to identify biomarkers, develop and validate predictive models for MDD diagnosis, antidepressant treatment response, and long-term outcomes, and explore biological pathways and potential therapeutic targets associated with MDD.\n\nThe study is expected to improve understanding of the biological heterogeneity of MDD and contribute to the development of objective approaches for diagnosis, treatment response prediction, personalized care, and future therapeutic discovery.",[209],"Major Depressive Disorder (MDD)",{"date":211,"type":33},"2026-08-03",{"date":213,"type":22},"2027-09-01",{"date":215,"type":22},"2028-02-01",{"name":38,"class":39},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":202,"sex":17,"minAge":171,"maxAge":172,"enrollmentInfo":223,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":40},"100574056","pathogenesis-of-pediatric-obsessive-compulsive-disorder-based-on-the-microbiota-gut-brain-axis-100574056","NCT06754319","Pathogenesis of Pediatric Obsessive-compulsive Disorder: Based on the Microbiota-gut-brain Axis","We recruited outpatient children and adolescents with OCD confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (4th edition). The following inclusion and exclusion criteria were also applied:\n\nInclusion Criteria:\n\n(1) 7-17 years old, (2) Y-BOCS score ≥16, (3) with or without a history of TD, (4) Drug-naïve or drug-free for 8 weeks, (5) Wechsler IQ score ≥ 80.\n\nExclusion Criteria:\n\n* History of serious medical, neurological illness or other psychotic disorders other than OCD (tic disorder excepted).\n* Previous exposure to cognitive behavioral therapy (CBT) for OCD or TD.\n* serious suicide risk.\n* Has taken antibiotics, probiotics, prebiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within the past 8 weeks.\n* Has a history of gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, constipation, hemorrhoids, or a history of gastrointestinal surgery, or has a history of autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus.\n* Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.",{"count":224,"type":22},125,"This study aims to investigate the characteristics of the microbiota-gut-brain axis in pediatric patients with obsessive-compulsive disorder (OCD) through performing an integrated analysis of gut microbiota, serum metabolomics, neuroimaging and electroencephalography (EEG), conducted before and after treatment with selective serotonin reuptake inhibitors (SSRIs). The results will be compared with those of pediatric OCD paitents comorbid with tic disorder (TD) and healthy controls. The findings are expected to further elucidate the potential pathogenesis of OCD, providing a theoretical basis for identifying novel clinical intervention targets and optimizing treatment strategies.",[227,228],"Obsessive-Compulsive Disorder","Tic Disorder",[230,231,232],"microbiota-gut-brain axis","pediatric OCD","microbiome",{"date":211,"type":33},{"date":235,"type":33},"2024-08-24",{"date":237,"type":22},"2027-12-31",{"name":38,"class":39},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":202,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":40},"100649299","online-fbt-dbt-caregiver-intervention-for-caregivers-of-individuals-with-anorexia-nervosa-100649299","NCT07734779","Online FBT-DBT Caregiver Intervention for Caregivers of Individuals With Anorexia Nervosa","A Randomized Controlled Trial of an Online Family-Based Treatment (FBT) Combined With Dialectical Behavior Therapy (DBT) Intervention Versus Online Supportive Psychological Intervention for Reducing Caregiver Burden Among Caregivers of Individuals With Anorexia Nervosa","Inclusion Criteria:\n\n* Primary caregiver of an individual diagnosed with anorexia nervosa (AN) by a qualified clinician.\n\nThe individual with AN is between 10 and 18 years of age. The individual with AN does not have a severe comorbid physical illness or severe psychiatric disorder.\n\nThe caregiver lives in the same household as the individual with AN. The caregiver has at least a primary school level of education and is able to complete study procedures and questionnaires.\n\nAll participating caregivers from the same family are willing to participate in the intervention and assessment procedures.\n\nAble and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Currently providing care for another family member with a chronic physical illness or psychiatric disorder.\n\nCurrent or past history of a severe physical illness or severe psychiatric disorder that would interfere with study participation.\n\nSevere emotional instability, active self-harm or suicidal behavior, psychotic symptoms, or other psychiatric conditions requiring immediate clinical intervention.\n\nUnable or unwilling to participate in the intervention or assessment procedures.",{"count":247,"type":22},100,[25],"Anorexia nervosa (AN) is a severe psychiatric disorder characterized by a chronic and relapsing course. Caregivers of individuals with AN often experience substantial caregiving burden, emotional distress, and impairment in family functioning due to their ongoing responsibilities in meal supervision, treatment support, and symptom management. Despite the critical role of caregivers in treatment and recovery, evidence-based interventions specifically targeting caregiver burden remain limited in China.\n\nThis study aims to develop and evaluate an online intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) for caregivers of individuals with AN. FBT emphasizes empowering caregivers to support nutritional rehabilitation and recovery, whereas DBT provides skills in emotion regulation, validation, and effective communication. The integration of these approaches may help caregivers reduce distress, improve caregiving skills, and enhance family functioning.\n\nThis study will employ a randomized controlled trial design. A total of 80 primary caregivers of individuals with AN will be recruited and randomly assigned to either an online FBT-DBT intervention group or an online supportive psychological intervention group. Both interventions will be delivered in a group format over 12 weeks. Assessments will be conducted at baseline, 4 weeks, 8 weeks, post-intervention (12 weeks), and at 1-month and 3-month follow-up. The primary outcome will be caregiver burden. Secondary outcomes will include psychological distress, negative emotional experiences, and the impact of eating disorder symptoms on the family.\n\nThe study aims to determine the effectiveness of the online FBT-DBT intervention in reducing caregiver burden and psychological distress and to evaluate whether it provides greater benefits than supportive psychological intervention. Findings may contribute to the development of accessible and evidence-based caregiver interventions for families affected by AN in China.",[251,252],"Anorexia Nervosa","Caregiver Burden","2026-07-24",{"date":255,"type":33},"2026-07-29",{"date":257,"type":33},"2026-04-03",{"date":259,"type":22},"2027-01-20",{"name":38,"class":39},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100597174","an-iso-principle-based-music-intervention-for-reducing-stress-anxiety-and-depression-100597174","NCT07055061","An ISO Principle-Based Music Intervention for Reducing Stress, Anxiety, and Depression","ISO4SAD","Inclusion Criteria:\n\n\\- Minimum of a secondary specialized school degree (vocational college) or higher\n\nExclusion Criteria:\n\n* Self-reported current or recent use of medication or history of surgical treatment\n* Self-reported history of psychiatric disorders\n* Self-reported hearing impairments\n* Female participants who are self-reported currently pregnant or breastfeeding","60 Years",{"count":270,"type":22},2000,[25],"This study aims to evaluate the effectiveness of a music-based intervention, guided by the ISO principle, in reducing stress, anxiety and depression induced by work, family or others among adults. The ISO principle suggests that emotional regulation can be supported by gradually modifying the emotional characteristics of music to help individuals transition to a desired emotional state.\n\nParticipants in this study will be randomly assigned to either a music intervention group or a control group. The intervention group will receive personalized music playlists designed to help reduce stress, anxiety and depression. The control group will not receive any music intervention during the same period.\n\nOutcomes will be measured using self-report questionnaires assessing stress, emotional state, and well-being. The study is designed to contribute to the development of accessible, non-invasive stress management tools using music as a behavioral intervention.",[274,275,276],"Stress","Anxiety","Depression in Adults",[278,279,280],"music intervention","emotion regulation","ISO principle","2026-07-22",{"date":283,"type":33},"2026-07-23",{"date":285,"type":33},"2024-04-23",{"date":287,"type":22},"2026-12-31",{"name":38,"class":39},2,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":300,"conditions":301,"keywords":306,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":40},"100648085","a-computer-assisted-tool-for-objective-assessment-of-extrapyramidal-symptoms-100648085","NCT07715994","A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms","Development of an Objective Quantitative Assessment and Computer-Assisted Diagnostic Tool for Extrapyramidal Symptoms","Inclusion Criteria\n\nA. Control Group\n\n1. Aged 18 to 80 years, with no restriction on sex.\n2. No current or past history of a psychiatric disorder meeting ICD-10 or DSM-5 criteria.\n3. No current or past history of central nervous system disease, such as primary Parkinson's disease or epilepsy, and no severe physical illness.\n4. No use within the 3 months before screening of medications that may cause extrapyramidal symptoms, such as antipsychotics or certain antiemetic medications.\n5. Sufficient visual, auditory, and cognitive ability to understand and cooperate with the standardized device-side assessment task sequence.\n6. Full understanding of the purpose and exploratory research nature of the study, voluntary participation, and provision of written informed consent.\n\nB. EPS Disease Group\n\n1. Aged 18 to 80 years, with no restriction on sex.\n2. Diagnosis of schizophrenia or a related psychotic disorder according to ICD-10 criteria.\n3. Regular treatment with one or more antipsychotic medications for at least 4 weeks.\n4. Clinically confirmed antipsychotic-induced extrapyramidal symptoms meeting at least one of the following criteria:\n\n   1. Drug-induced parkinsonism: a total score of 2 or higher on Items 1, 2, 3, 4, 5, and 9 of the Simpson-Angus Scale (SAS).\n   2. Akathisia: a score of 2 or higher on the Global Clinical Assessment item of the Barnes Akathisia Rating Scale (BARS).\n   3. Tardive dyskinesia: a score of 3 or higher on any one of Items 1 through 7 of the Abnormal Involuntary Movement Scale (AIMS), or a score of 2 or higher on any two of these items.\n5. Sufficient visual, auditory, and cognitive ability to understand and cooperate with the standardized device-side assessment task sequence.\n6. Full understanding of the purpose and exploratory research nature of the study, voluntary participation, and provision of written informed consent by the participant or, where applicable, the participant's legal guardian.\n\nExclusion Criteria\n\nThe following exclusion criteria apply to both groups:\n\n1. Primary neurological or organic movement disorders that may affect the assessment results, such as primary Parkinson's disease, Huntington's disease, Wilson's disease, or sequelae of stroke.\n2. Severe musculoskeletal disease, recent fracture, limb disability, or other physical conditions that prevent completion of the required assessment tasks.\n3. Acute exacerbation of psychiatric symptoms with severe agitation, impulsivity, stupor, or severe cognitive impairment that prevents safe and adequate cooperation with the assessment.\n4. Severe deformity of the face or tested limbs, large dark-colored tattoos, or severe non-removable occlusion that may substantially interfere with computer-vision-based assessment.\n5. Poorly fitting removable dentures or frequent compensatory oral movements that may interfere with objective assessment of orofacial movements.\n6. Any condition that, in the investigator's judgment, may affect participant safety, substantially compromise data quality, or make the individual unsuitable for participation.","80 Years",{"count":299,"type":22},180,"This prospective, single-center observational study aims to develop and validate a computer-assisted tool for the objective quantitative assessment of extrapyramidal symptoms (EPS).\n\nThe study will enroll 180 participants, including 90 healthy controls and 90 participants with clinically confirmed antipsychotic-induced EPS. The healthy control group will provide reference data on normal movement, while the EPS disease group will provide data on abnormal movements associated with drug-induced parkinsonism, akathisia, or tardive dyskinesia.\n\nEach participant will complete one study visit lasting approximately 60 minutes. During the visit, a trained psychiatrist will assess EPS using the Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS). Participants will also complete standardized movement tasks while a non-contact computer vision system records and analyzes movement features. The device-based assessment will be repeated after a short rest to evaluate the stability of the measurements.\n\nData collected earlier in the study will be used to develop and optimize the assessment tool. After the algorithm is finalized and locked, data from subsequently enrolled participants will be used for independent validation. The study will evaluate how closely the tool's results agree with clinician assessments, as well as its ability to identify EPS, produce stable repeated measurements, and operate feasibly and safely in a clinical setting.\n\nThis is an observational study. The study does not assign treatment, change participants' medications, or use the investigational tool to make treatment decisions.",[302,303,304,305],"Extrapyramidal Symptoms","Drug-induced Parkinsonism","Akathisia, Drug-Induced","Tardive Dyskinesia (TD)",[307,308,309,310],"Antipsychotic-Induced Extrapyramidal Symptoms","Objective Quantitative Assessment","Computer-Assisted Diagnosis","Computer Vision","2026-07-20",{"date":313,"type":33},"2026-07-21",{"date":315,"type":22},"2026-07",{"date":317,"type":22},"2027-04",{"name":38,"class":39},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":202,"sex":17,"minAge":326,"maxAge":204,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100645503","eye-movement-intervention-for-cognitive-impairment-across-schizophrenia-spectrum-100645503","NCT07702526","Eye-Movement Intervention for Cognitive Impairment Across Schizophrenia Spectrum","Effects of an Eye-Movement Intervention on Cognitive Impairment in Individuals Across Illness Stages of Schizophrenia: Protocol for a Stratified Randomized, Active-Controlled, Assessor-Blinded Trial","Inclusion Criteria:\n\n* Age between 15 and 45 years.\n* More than 9 years of education.\n* Normal or corrected-to-normal vision without color blindness, color weakness, strabismus, or nystagmus.\n* Right-handedness.\n* Impaired cognitive performance defined as a T-score \\\u003C40 in at least one MCCB cognitive domain at baseline.\n* Capacity to complete cognitive and eye-tracking assessments.\n* Clinical high-risk group: Meet psychosis-risk syndrome criteria based on SIPS\u002FSOPS, including attenuated positive symptoms or brief intermittent psychotic symptoms.\n* First-episode schizophrenia group: Meet DSM-5 criteria for schizophrenia, with first episode occurring within approximately 2 years of illness onset and minimal prior antipsychotic exposure.\n* Chronic schizophrenia group: Meet DSM-5 criteria for schizophrenia, with illness duration ≥5 years and stable treatment status for the previous 6 months.\n* Healthy control group: No current or past psychiatric disorders based on MINI 7.0 and no significant depressive symptoms based on the Hamilton Depression Rating Scale. Healthy controls will also meet the same general criteria regarding age, education, handedness, and vision.\n\nExclusion Criteria:\n\n* IQ \\\u003C70.\n* Severe or unstable medical or neurological illness (e.g., stroke, epilepsy, dementia, cardiac disease, or uncontrolled hypertension).\n* Substance abuse or dependence.\n* Clinically significant laboratory abnormalities.\n* Visual or auditory impairments affecting task performance.","15 Years",{"count":328,"type":22},160,[25],"The goal of this clinical trial is to determine whether a gamified eye-movement intervention can improve cognitive function in individuals across the schizophrenia spectrum, including clinical high-risk individuals, first-episode schizophrenia patients, and chronic schizophrenia patients. The main questions it aims to answer are:\n\n* Does eye-movement training improve cognitive performance measured by the MATRICS Consensus Cognitive Battery (MCCB)?\n* Does eye-movement training improve oculomotor functions and clinical symptoms across different illness stages?\n\nResearchers will compare an eye-movement intervention group with an active control group receiving matched finger-controlled game training to determine whether the eye-movement intervention produces greater improvements in cognitive function and eye-movement performance.\n\nParticipants will:\n\n* Receive either gamified eye-movement training or matched finger-controlled game training for 4 weeks.\n* Complete cognitive assessments using the MCCB before and after the intervention.\n* Complete standardized eye-tracking tasks, including fixation stability, smooth pursuit, antisaccade, and free-viewing tasks, to evaluate changes in oculomotor control and visual exploration patterns.\n* Complete clinical symptom assessments using SOPS or PANSS according to illness stage.",[125,332,333],"Cognitive Impairment","Clinical High Risk for Psychosis",[335,336,337,338,339],"Eye movement training","Cognitive remediation","BVMT-R","Visuospatial memory","Eye tracking","2026-07-08",{"date":342,"type":33},"2026-07-14",{"date":344,"type":22},"2026-07-01",{"date":346,"type":22},"2028-07-30",{"name":38,"class":39},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":364,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":374,"leadSponsor":376,"locationsCount":40},"100646528","the-efficacy-of-transcutaneous-auricular-vagus-nerve-stimulation-in-individuals-with-tiletamine-use-disorder-100646528","NCT07689981","The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder","Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Tiletamine Use Disorder: A Randomized Double-Blind Sham-Controlled Trial","taVNS-Tiletami","Inclusion Criteria:\n\n* Age 18-60 years ≥6 years of education\\[7.1\\] DSM-5 diagnosis of substance use disorder related to tiletamine Tiletamine use ≥6 months and ≥1 time\u002Fweek Ability to provide informed consent Willingness to complete follow-up assessments\n\nExclusion Criteria:\n\n* Severe cognitive impairment History of epilepsy, brain injury, neurological disease or serious psychiatric disease Use of cognition-enhancing medications within 6 months Other psychoactive substance abuse within past 5 years (except nicotine) Metal implants in the head or severe skin sensitivity",{"count":357,"type":22},30,[25],"Participants diagnosed with tiletamine use disorder will be assigned to active or sham taVNS for 5 days. Clinical outcomes ( e.g., behavioral paradigms measures and clinical scales ) and physiological markers (e.g., EEG and ECG) will be evaluated at baseline, post-treatment, and 3-month follow-ups to determine therapeutic efficacy and mechanisms of action.",[361,362,363],"Tiletamine Use Disorder","Substance Use Disorder (SUD)","Drug Craving",[365,366,367,368,369,370,363,371],"taVNS","Addiction","Brain-Heart Coupling","HRV","EEG","Neuromodulation","Tiletamine Dependence",{"date":340,"type":33},{"date":344,"type":22},{"date":375,"type":22},"2028-01-01",{"name":38,"class":39},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":202,"sex":384,"minAge":18,"maxAge":268,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":40},"100551218","cerebellum-prefrontal-paired-pulse-stimulation-for-methamphetamine-use-disorder-100551218","NCT06457230","Cerebellum-Prefrontal Paired-Pulse Stimulation for Methamphetamine Use Disorder","Exploring the Mechanisms and Efficacy of Cerebellum-Medial Prefrontal Cortex-Based Paired-Pulse Repetitive Transcranial Magnetic Stimulation for Methamphetamine Use Disorder","Inclusion Criteria\n\nParticipants will be eligible for inclusion if they meet the following criteria:\n\n1. Methamphetamine is the primary substance of use, and the participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate or severe methamphetamine use disorder;\n2. aged 18 to 60 years;\n3. normal or corrected-to-normal vision and hearing, and right-handedness;\n4. primary school education or above, with the ability to understand the questionnaires and behavioral task instructions.\n\nExclusion Criteria\n\nParticipants will be excluded if they meet any of the following criteria:\n\n1. presence of metal objects in the body, such as metal dentures, orthodontic braces, bone fixation plates, aneurysm clips, or other metallic implants;\n2. severe physical illness or chronic disease, including heart disease, severe hypertension, stroke, epilepsy, or history of head trauma;\n3. comorbid psychiatric disorders, such as bipolar disorder, schizophrenia, or severe depression;\n4. previous participation in transcranial magnetic stimulation- or electroencephalography-related studies;\n5. refusal to participate in the study, poor compliance, or any other contraindications to transcranial magnetic stimulation.","MALE",{"count":386,"type":22},90,[25],"To investigate the mechanism and efficacy of a novel repetitive transcranial magnetic stimulation (rTMS) intervention model with paired cerebellar-medial prefrontal cortex (mPFC) pulses on methamphetamine use disorder patients and to develop a novel physiotherapeutic intervention to optimise the treatment and management.",[84],[391,392,393,394,395],"Repetitive transcranial magnetic stimulation","Cerebellum","Methamphetamine","Cortico-Cortical Paired Associative Stimulation","medial prefrontal cortex","2026-06-21",{"date":398,"type":33},"2026-06-24",{"date":400,"type":33},"2024-12-24",{"date":402,"type":22},"2026-09",{"name":38,"class":39},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":424,"leadSponsor":425,"locationsCount":40},"100585571","efficacy-and-mechanisms-of-tus-on-cognitive-deficits-in-schizophrenia-based-on-the-hippocampal-prefrontal-circuit-100585571","NCT06904092","Efficacy and Mechanisms of TUS on Cognitive Deficits in Schizophrenia: Based on the Hippocampal-Prefrontal Circuit","Efficacy and Mechanisms of Transcranial Ultrasound Stimulation (TUS) on Cognitive Deficits in Schizophrenia：Based on the Hippocampal-Prefrontal Circuit","Inclusion Criteria:\n\n* Meet the DSM-5 diagnostic criteria for schizophrenia ;\n* Age18-50, right-handed, Han nationality;\n* Presence of cognitive deficit: defined as d' value \\\u003C0.5 in associative memory test;\n* Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;\n* Written informed consent;\n\nExclusion Criteria:\n\n* Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnancy or lactation;\n* Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.;\n* History of MECT or other physical therapy within 6 months;\n* History of epilepsy, or epileptic waves on the baseline EEG;\n* Ruled out share antiepileptic drugs (carbamazepine, valproic acid salt) or larger doses of benzodiazepine drugs (diazepam \\> 10mg\u002Fday, clonazepam \\> 2mg\u002Fday etc.), if necessary, remain unchanged during the course of treatment;\n* Contraindications to TUS and MRI are present.","50 Years",{"count":413,"type":22},140,[25],"Cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome. Prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate\u002FGABA imbalances may lead to cognitive deficits. Based on the current background and our previous studies, it has been proved that TUS can modulate neural excitability and plasticity in the hippocampus. In this double-blind, randomized study, the efficacy of different treatment options and mechanisms of TUS on cognitive deficits will be investigated.",[417],"Cognitive Deficit in Schizophrenia",[419],"Schizophrenia; Cognitive Deficit; Transcranial Ultrasound Stimulation; Hippocampus- Prefrontal Circuit","2026-06-10",{"date":422,"type":33},"2026-06-12",{"date":344,"type":22},{"date":237,"type":22},{"name":38,"class":39},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":411,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":440,"leadSponsor":442,"locationsCount":40},"100643368","the-efficacy-and-safety-of-temporal-interference-stimulation-in-the-treatment-of-post-traumatic-stress-disorder-100643368","NCT07644338","The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n1. Age 18-50 years, male or female\n2. Diagnosis of PTSD per DSM-5 (assessed by CAPS-5), with symptom duration of at least 3 months, and PTSD as the current primary diagnosis; comorbid depressive disorder or anxiety disorder is allowed\n3. If currently receiving psychiatric medication, the dosage must be stable for at least 4 weeks prior to enrollment\n4. At least 9 years of education (junior high school or above)\n\nExclusion Criteria:\n\n1. Any DSM-5 diagnosis other than PTSD, depressive disorder, or anxiety disorder\n2. PTSD symptoms too severe to complete required assessments\n3. Received electroconvulsive therapy (ECT) within the past 6 months\n4. Received any other form of neuromodulation within the past 2 months (see Item 3 for ECT)\n5. Severe medical illness or any condition that may induce seizures or intracranial hypertension (e.g., cardiovascular or respiratory diseases)\n6. History of neurological disorders (e.g., epilepsy, cerebrovascular accident) or brain injury\u002Fsurgery\n7. Presence of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or any other MRI-incompatible implants\n8. Current significant suicidal behavior risk per investigator judgment\n9. Pregnancy or planning to become pregnant during the study period\n10. Initiation of structured psychotherapy for PTSD within 3 months prior to screening, with expected change during the 10-week treatment period",{"count":80,"type":22},[25],"This study aims to evaluate the efficacy and safety of Temporal Interference (TI) stimulation in treating patients with post-traumatic stress disorder (PTSD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) ,magnetoencephalography（MEG）,electroencephalography (EEG).",[436],"Post-traumatic Stress Disorder (PTSD)","2026-06-08",{"date":422,"type":33},{"date":437,"type":33},{"date":441,"type":22},"2027-06",{"name":38,"class":39},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":40},"100610484","effect-of-high-intensity-transcranial-alternating-current-stimulation-on-gambling-disorder-a-randomized-controlled-trial-100610484","NCT07228182","Effect of High-Intensity Transcranial Alternating Current Stimulation on Gambling Disorder: A Randomized Controlled Trial","HITACSRCT-GD","Inclusion Criteria:\n\n* Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests;\n* Meet DSM-5 (Diagnostic and Statistical Manual of mental disorders，DSM) diagnostic criteria for gambling disorder;\n* Have gambled for at least one year (at least once a week);\n* Normal vision and hearing, or within the normal range after correction;\n* Agree to cooperate in the follow-up evaluation;\n* No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity.\n\nExclusion Criteria:\n\n* Have severe cognitive impairment, such as a history of head trauma, -cerebrovascular disease, epilepsy, etc.;\n* Have used drugs promoting cognitive function in the last 6 months;\n* Have impaired intelligence (Intelligence Quotient\\\u003C70);\n* Abuse or dependence of psychoactive substances (except nicotine) in the last 5 years.",{"count":451,"type":22},60,[25],"The investigators assume that High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. This study intends to validate the effect of HI-tACS treatment, which has been discovered in the previous pilot study. A three-month follow-up assessment will be conducted to test the changes in executive-control function and its underlying mechanism.",[455],"Gambling Disorder",[457],"High-Intensity Transcranial Alternating Current Stimulation, Gambling disorder.",{"date":420,"type":33},{"date":460,"type":22},"2026-06-01",{"date":462,"type":22},"2026-12-28",{"name":38,"class":39},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":471,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":40},"100451503","mental-health-during-the-whole-life-cycle-of-community-patients-with-schizophrenia-100451503","NCT05159349","Mental Health During the Whole Life Cycle of Community Patients With Schizophrenia","Mental Health During the Whole Life Cycle of Community Patients With Schizophrenia: a Cohort Study","Inclusion Criteria:\n\n* Registered in the Shanghai Mental Health Information Management System.\n* Meets criteria for the diagnosis of schizophrenia (ICD-10 or ICD-11).\n* Patients with schizophrenia diagnosed within five years.\n* Aged between 18 and 65 years.\n\nExclusion Criteria:\n\n* Patients with severe physical diseases and organic brain diseases.\n* The patient is about to settle outside Shanghai.",{"count":472,"type":22},1200,"Schizophrenia is one of the components of severe mental disorders. It has the characteristics of prolonged course, low cure rate, high recurrence rate and high disability rate. It brings many short-term and long-term effects to individuals, families and society. Studies on patients with schizophrenia mainly focus on cross-sectional and case-control studies, but there is a lack of long-term follow-up of patients with schizophrenia in the community. Therefore, this study would establish a cohort study to solve the chronological relationship between exposure and effect, focus on community schizophrenia, and establish a community schizophrenia patient biobank that has been tracked for a long time from diagnosis.",[125],[125,476,477,478],"Cohort study","The whole life cycle","Mental health","2026-06-04",{"date":437,"type":33},{"date":482,"type":33},"2021-12-01",{"date":484,"type":22},"2027-12",{"name":38,"class":39},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":493,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":4},"100639183","multimodal-pharmacological-study-of-clinical-cohorts-for-major-depressive-disorder-100639183","NCT07602153","Multimodal Pharmacological Study of Clinical Cohorts for Major Depressive Disorder","Multimodal Pharmacological Study of Clinical Cohorts for Major Depressive Disorder - Sub-task 2: A Longitudinal Imaging-Proteomics Study on Suicidal Tendency and Mechanisms of Rapid Antidepressant Effects","Inclusion Criteria:\n\nAge 18-65; Han Chinese; meets DSM-5 criteria for MDD; suicidal ideation (HAMD-17 Item 3 score ≥ 2); education above primary school; provided written informed consent.\n\nExclusion Criteria:\n\nOther major mental disorders; unstable physical diseases (cardiovascular, hepatic, etc.); pregnancy or lactation; contraindications to Ketamine or ECT; history of drug or alcohol abuse within 6 months.",{"count":494,"type":22},130,"This study focuses on the neurobiological changes in MDD patients with high suicidal risk during rapid antidepressant treatments, such as Esketamine and Electroconvulsive Therapy (ECT). Core ObjectivesEstablish a standardized longitudinal cohort for high-risk suicidal populations to ensure high-quality data for clinical transformation. Investigate the biological mechanisms of rapid-acting interventions by analyzing changes in brain function and molecular pathways. Develop predictive biomarkers to identify treatment responders early, thereby reducing ineffective trial-and-error treatments and lowering suicide risk. Methodology \\& Data CollectionThe study integrates multi-dimensional data across three critical time points: T0 (Baseline), T1 (Acute Phase\u002F24h post-first treatment), and T2 (Remission Phase\u002F4-6 weeks). Sample Cohort: A total of 130 participants (70 ECT, 30 Esketamine, 30 conventional medication). Multimodal Data Integration:Clinical Phenotyping: Standardized scales including HAMD-17 (Primary Indicator), C-SSRS (Suicide Assessment), and QIDS-SR16. Biological Omics: Whole Genome Sequencing (WGS), single-cell sequencing, proteomics, metabolomics, DNA methylomics, and gut metagenomics. Neuroimaging \\& Physiology: Functional MRI (fMRI), Diffusion Tensor Imaging (DTI), and 32-channel resting-state EEG. SignificanceBy capturing dynamic \"treatment-response\" trajectories, the project aims to move beyond descriptive symptoms to a system biology-based diagnosis. The findings are expected to provide scientific evidence for individualized intervention strategies and improve the efficiency of care for patients with treatment-resistant depression and acute suicidal ideation.",[497],"Major Depressive Disorder (MDD","2026-05-17",{"date":500,"type":33},"2026-05-22",{"date":502,"type":22},"2026-05-30",{"date":237,"type":22},{"name":38,"class":39},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":411,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":40},"100635606","phase-1-study-of-neural-stem-cell-derived-exosomes-in-moderate-to-severe-early-onset-alzheimers-disease-100635606","NCT07554872","Study of Neural Stem Cell-Derived Exosomes in Moderate-to-Severe Early-Onset Alzheimer's Disease","A Phase I, Open-Label, Single-Center, Frequency-Escalation Study of the Safety, Tolerability, and Preliminary Efficacy of Neural Stem Cell-Derived Exosomes in Patients With Moderate-to-Severe Early-Onset Alzheimer's Disease","* Inclusion Criteria:\n* Male or postmenopausal female, aged 50 to 75 years.\n* Meets the 2011 NIA-AA criteria for probable Alzheimer's disease dementia.\n* Age at onset ≤65 years.\n* CMMS score 5-20\n* Stable dose for at least 2 months before enrollment if receiving pro-cognitive or psychiatric medications.\n* Primary school education or above and able to complete study-required cognitive assessments.\n* Hachinski Ischemic Score ≤4.\n* GDS-30 total score ≤10.\n* Screening brain MRI+DWI+SWI meeting protocol-defined cerebrovascular exclusion thresholds and no major structural abnormalities inconsistent with Alzheimer's disease.\n* Positive amyloid pathology confirmed by Aβ-PET at screening or before enrollment.\n* Adequate vision and hearing to complete assessments.\n* Has a reliable caregiver able to accompany the participant to study visits and provide information for assessments.\n* Willing to participate and sign informed consent.\n\nExclusion Criteria:\n\n* Dementia due to causes other than Alzheimer's disease.\n* Brain MRI showing any of the following: Fazekas white matter hyperintensity score \\>2; more than 2 lacunar infarcts \\>1.5 cm; lacunar infarcts involving critical regions such as the thalamus, hippocampus, entorhinal cortex, or parahippocampal region; cerebral hemorrhage, subdural hematoma, aneurysm, arteriovenous malformation, intracranial mass lesion, or other clinically significant structural abnormalities.\n* Allergy to stem cell-derived exosomes or PET examination.\n* Severe psychiatric disorder or symptoms.\n* Significant active physical illness, including severe cardiac disease, severe systemic infection, or severe liver\u002Fkidney dysfunction.\n* Elevated tumor markers or tumor history.\n* Immune-related disease.\n* Significant nasal obstruction.\n* Serious suicide risk.\n* Participation in another clinical trial or stem cell therapy within the past 6 months.\n* Any other condition judged inappropriate by the investigator.\n* Contraindications to MRI or inability to complete MRI examinations, including non-MRI-compatible metallic implants, certain stents, plates, pacemakers, or severe claustrophobia.","75 Years",{"count":514,"type":22},9,[121],"This is an open-label, single-center, phase I clinical study in patients with moderate-to-severe early-onset Alzheimer's disease. The study aims to evaluate the safety, tolerability, and preliminary efficacy of neural stem cell-derived exosomes (NSC-EVs) administered by the intranasal route. A total of 9 participants will be enrolled in 3 frequency-escalation groups: once every 3 days, once every other day, and once daily, each for 28 days. Participants will undergo screening and baseline assessment, a 28-day treatment period, and follow-up visits at 4, 8, and 24 weeks after the end of treatment.",[518],"Alzheimer Disease (AD)",[520,521,522,523,524,525,526,527],"Early-Onset Alzheimer's Disease","Moderate-to-Severe Alzheimer's Disease","Neural Stem Cell-Derived Exosomes","Intranasal Administration","Phase I Clinical Study","Frequency Escalation","Safety","Tolerability","2026-05-13",{"date":530,"type":33},"2026-05-15",{"date":532,"type":22},"2026-05",{"date":484,"type":22},{"name":38,"class":39},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":40},"100635799","the-effect-of-game-based-intervention-on-the-cognition-of-schizophrenia-patients-100635799","NCT07557381","The Effect of Game-Based Intervention on the Cognition of Schizophrenia Patients","The Effect of a 2-month Somatic Serious Games on the Cognition of Schizophrenia Patients","Inclusion Criteria:\n\n1. Registered in the Shanghai Mental Health Information Management System and hospitalized in the designated district-level mental health center wards;\n2. Schizophrenia patients meeting the diagnostic criteria of schizophrenia in the International Classification of Diseases (ICD-10);\n3. 18 - 45 years old;\n4. Good self-care ability;\n5. Clinically stable (without acute exacerbation) for at least 1 week before enrollment, with a stable dose of antipsychotic drugs or other concomitant psychotropic drugs for at least 1 week;\n6. No hand disabilities, and can use mobile phones or tablets normally;\n7. Have a primary school education or above;\n8. Normal vision and hearing, or within the normal range after correction;\n9. Own and be able to independently use a smart phone or other electronic devices;\n10. Patients and their families have given informed consent to this study, and voluntarily cooperate to participate in the intervention and sign the informed consent form.\n\nExclusion Criteria:\n\n1. not reside in Shanghai after discharge;\n2. suffering from serious physical or brain organic diseases;\n3. comorbid with other psychotic disorders.",{"count":543,"type":22},84,[25],"Schizophrenia is a common and severe mental disorder that imposes a significant burden on patients. Cognitive impairment can be regarded as one of the core symptoms of schizophrenia, which is prevalent among patients with schizophrenia. In recent years, digital rehabilitation therapy based on games has shown a remarkable development trend among schizophrenia patients. Serious games, or application games, refer to those games aimed not only for entertainment. They can educate, train, or change the behavior of players through interesting intervention forms and have been applied in many healthcare fields. This study aims to develop a somatosensory interactive game for patients with cognitive impairment of schizophrenia to improve their cognitive functions and verify its effectiveness and feasibility through a randomized controlled trial.",[125],[548,125,549],"Cognition","Game-Based Intervention","2026-05-05",{"date":552,"type":33},"2026-05-11",{"date":554,"type":33},"2026-04-19",{"date":556,"type":22},"2028-07",{"name":38,"class":39},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":566,"conditions":567,"keywords":568,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":574,"leadSponsor":575,"locationsCount":40},"100635798","effects-of-gamified-rehabilitation-on-cognitive-and-psychosocial-outcomes-in-inpatients-with-schizophrenia-100635798","NCT07557368","Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia","Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia: A Randomized Controlled Trial[",{"count":543,"type":22},[25],"Schizophrenia is a severe and chronic mental disorder that profoundly impacts patients' psychological, social, and occupational functions. Cognitive impairment is a core symptom that severely limits daily living abilities. Systematic rehabilitation is crucial for delaying disease progression and improving social functions.\n\nTraditional rehabilitation typically relies on pharmacological treatments and conventional cognitive remediation therapies. However, cognitive training alone rarely translates spontaneously into real-world functional improvement; integration with functional skills training is generally required before meaningful gains in daily living are achieved. Furthermore, traditional interventions are typically delivered in contexts detached from patients' everyday lives and are often perceived as monotonous, resulting in poor treatment adherence and compromised long-term rehabilitation outcomes.\n\nWith the development of digital health technologies, gamified interventions offer new opportunities for psychiatric rehabilitation. Among these innovative approaches, integrating psychoeducation with interactive storytelling has shown unique advantages. Such immersive narrative contexts can effectively enhance patients' illness awareness, treatment motivation, and medication adherence. Nevertheless, existing digital tools still have room for improvement. On one hand, many applications are confined to static screen-based interactions, overlooking the elevated somatic disease burden and sedentary risks prevalent in this population. On the other hand, existing applications rarely successfully integrate cognitive interventions with coherent psychosocial interventions, making it difficult for cognitive improvements to genuinely translate into real-life skills.\n\nTo this end, the present study developed an interactive digital rehabilitation application specifically designed for individuals with schizophrenia. This intervention innovatively combines cognitive remediation with psychosocial rehabilitation through two distinct yet highly complementary modules: a sensory-motion cognitive module, which leverages the built-in motion-sensing capabilities of mobile devices to engage patients in moderate physical activity while performing cognitive tasks; and an interactive narrative module, encompassing medication management, symptom management, psychological recovery, and social rehabilitation. Through a randomized controlled trial, this study evaluates the practical effectiveness of this multimodal approach in improving patients' overall rehabilitation outcomes, ultimately seeking to provide a highly engaging rehabilitation pathway that facilitates the transfer of skills to daily life.",[125],[569,125,570,571],"Gamified Rehabilitation","Cognitive","Psychosocial",{"date":552,"type":33},{"date":554,"type":33},{"date":556,"type":22},{"name":38,"class":39},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":202,"sex":17,"minAge":18,"maxAge":582,"enrollmentInfo":583,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":594,"locationsCount":40},"100638677","an-exploratory-study-on-the-prediction-of-recurrence-risk-of-bipolar-disorder-using-sentiment-analysis-technology-based-on-multi-modal-feature-fusion-100638677","NCT07573839","An Exploratory Study on the Prediction of Recurrence Risk of Bipolar Disorder Using Sentiment Analysis Technology Based on Multi-modal Feature Fusion","Patients group inclusion criteria:\n\n* Patients who have previously met or currently meet the diagnostic criteria for bipolar disorder according to DSM-5, whose condition and treatment are currently stable, and who cooperate with the assessment;\n* Age ≥18 years, \\\u003C65 years;\n* Han Chinese ethnicity;\n* Sufficient visual and auditory abilities to complete the necessary examinations for the study;\n* Understanding the study content and signing the informed consent form. If the patient is unable to sign the informed consent form personally due to low education level or other reasons, it may be signed by a relative or guardian on their behalf.\n\nexclusion criteria:\n\n* The presence of intellectual disability or other conditions that significantly affect the patient's current mental state;\n* the patient has a serious or unstable physical illness, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumors, immunodeficiency, and blood glucose levels higher than 12 mmol\u002FL; or other diseases that may interfere with the test assessment (abnormal indicators more than twice the normal value).\n\nHealthy controls group inclusion criteria:\n\n* Age ≥ 18 years, \\\u003C 65 years;\n* Han Chinese ethnicity;\n* Gender matched to the patient group;\n* Sufficient visual and auditory ability to complete the necessary examinations for the study;\n* Understanding of the study content and signing of informed consent;\n* No family history of mental illness. exclusion criteria:\n* Individuals with a mental disorder conforming to DSM-5, or those with suspicious mental symptoms but not meeting the diagnostic criteria;\n* Individuals with severe physical illness that makes it difficult to complete the necessary examinations.","64 Years",{"count":149,"type":22},"Bipolar disorder (BD) has become a significant public health problem with complex clinical manifestations, difficult treatment, and poor prognosis. However, there is still a lack of effective biological markers for diagnosing and predicting recurrence. Sentiment analysis computing usually refers to using machine equipment to classify, identify, interpret, and imitate human emotions. However, current multi-modal emotion analysis research is mainly based on one or two modalities. Due to the diversity and complexity of patients' emotional expressions, this single- and dual-modal information analysis is far from enough for accurate discrimination of emotional symptoms. Only emotion analysis technology based on multi-modal feature fusion can make more precise and effective judgments. The current project is based on our previous research on cognitive neuroimaging and big data analysis of bipolar disorder. The investigators plan to enroll 200 BD patients who meet DSM-5 diagnostic criteria and 200 healthy controls. The investigators will use sentiment analysis technology with multi-modal feature fusion (text data, audio and visual modalities, eye movements, and electrophysiology) to identify BD recurrence. Biological markers for risk prediction and an algorithm model for joint judgment of multi-source information will be established to analyze the characterization data. The effectiveness of this recurrence prediction model will be further verified and optimized through a large-sample, prospective cohort study design. It is hoped that it can provide a new method for predicting the recurrence risk of BD patients. In the near future, clinical decision-making aids based on this auxiliary method can be developed, and the translational application value of clinical diagnosis and treatment can be explored.",[586,587],"Bipolar Disorder (BD)","Healthy Control","2026-05-01",{"date":590,"type":33},"2026-05-07",{"date":592,"type":22},"2026-04",{"date":484,"type":22},{"name":38,"class":39},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":602,"maxAge":204,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":609,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":618,"leadSponsor":620,"locationsCount":40},"100635930","multi-target-tms-for-schizophrenia-negative-symptoms-100635930","NCT07559084","Multi-target TMS for Schizophrenia Negative Symptoms","Development of a Multi-target Transcranial Magnetic Intervention Technique for Negative Symptoms of Schizophrenia","Inclusion Criteria:\n\n1. Outpatients or inpatients at the Department of Psychiatry, Shanghai Mental Health Center;\n2. Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for first-episode schizophrenia (diagnosed using the Structured Clinical Interview for DSM-5, SCID-5); disease duration less than 5 years at enrollment;\n3. Male or female aged 16-45 years;\n4. Education duration ≥ 9 years;\n5. Stable medication regimen for at least 6 weeks prior to baseline visit and throughout the study period; psychiatric symptoms generally stable within 1 month prior to baseline visit;\n6. Participants and their guardians can understand and sign written informed consent;\n7. Total score on the PANSS Negative Symptom subscale (PANSS-N) \\> 15, and at least one item score ≥ 3.\n\nExclusion Criteria:\n\n1. Current or lifetime psychiatric disorders as determined by SCID-5 assessment;\n2. Severe or unstable physical illnesses, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension, hyperglycemia, malignant tumors, and immunocompromised conditions;\n3. Alcohol abuse within 30 days prior to the study or alcohol\u002Fdrug dependence within 6 months prior to the study; participation in any clinical trial within 30 days prior to baseline;\n4. Pregnant or breastfeeding women;\n5. Intellectual disability (IQ \\\u003C 70).","16 Years",{"count":604,"type":22},64,[25],"This randomized controlled trial (RCT) is the first to evaluate the efficacy and safety of a multi-target TMS protocol targeting the left dorsolateral prefrontal cortex (L-DLPFC), left inferior parietal lobule (L-IPL), and right orbitofrontal cortex (R-OFC) for negative symptoms of schizophrenia.",[608],"SCHIZOPHRENIA 1 (Disorder)",[59,610,611,612,613],"TMS","repetitive transcranial magnetic stimulation","rTMS","TBS","2026-04-26",{"date":616,"type":33},"2026-04-30",{"date":588,"type":22},{"date":619,"type":22},"2028-01-30",{"name":38,"class":39},""]