[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650222":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":48,"locations":38,"responsibleParty":54,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":38,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":90,"whyStopped":38,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":38},{"fullName":5,"class":6},"University of New Mexico","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Neurofeedback","SHAM_COMPARATOR","You will undergo 2 sessions of neurofeedback treatment, with an interval of 1-2 weeks between sessions up to a month maximum. Neurofeedback training and treatment in this study is performed inside an MRI scanner while wearing a cap to measure brain waves (EEG). You will be lying comfortably inside an MRI machine for 1 hour while your brain activity is being scanned. You will see a screen with a thermometer-style red bar, which will represent activity of a specific region of your brain (the amygdala), involved in emotion experience in the active condition. For those assigned to the sham condition, the red bar will not represent brain activity and will move randomly. By controlling the height of the red bar in real time, you will be able to try to regulate activity of that brain region. By controlling the neurofeedback signal, you may learn to enhance your brain activity associated with happy future thoughts.",[13],"Behavioral: Neurofeedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: TMS","ACTIVE_COMPARATOR","The day before you begin the rTMS treatments, you will be asked to come in for a short visit to determine the level of stimulation that is right for you. You will then receive up to 100 rTMS treatments, given five days a week for 10 days. For the first 50 treatments, you will receive real stimulation to the left side of your brain. After 50 treatments to the left side, depending on how it affects you, you may qualify to receive 50 more treatments to the right side of your brain.\n\nYou might feel a slight twitch in your hand. A camera will track your head movements during the procedure. Most people experience tapping or twitching on their scalp during rTMS. The stimulation will last 10 minutes, followed by 30 minutes of rest before another session.",[19],"Device: Transcranial Magnetic Stimulation",{"label":21,"type":16,"description":22,"interventionNames":23},"Arm 3: Psilocybin","You may receive 2 psilocybin assisted therapy treatments, given once a week, for 2 weeks.\n\nPreparation Sessions: Before the first psilocybin session, you will meet with the study therapist and physician for 1-2 preparation meetings, to answer questions and make sure you understand the sequence of events during the intervention.\n\nPsilocybin Session: You will lie on a comfortable couch, receive the medication and be guided through the psychedelic experience with the two trained study staff, while being medically monitored, for approximately 8 hours. If needed, you may receive medications to treat side effects like high blood pressure, or anxiety. You will need to have a trusted person to take you home and stay with you for the night after each psilocybin session.\n\nIntegration Session: The next day after each psilocybin session, you will meet with the therapist again and talk about your experience. Depending on what you experienced in the first week, the dose may be increased.",[24],"Drug: Psilocybin (drug)",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Transcranial Magnetic Stimulation","This intervention will deliver open-label aiTBS, an efficient FDA-cleared form of rTMS for major depressive disorder to patients with intermediate\u002Fhigh risk (i.e., significant depression and anxiety; chronic suicidal ideation). The study team will conduct modeling of the electric field intensity and distribution for each participant, and provide proof of concept for an electric-field informed dosing strategy that engages brain networks.",[15],[32],"TMS",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Psilocybin (drug)","In this intervention, open-label flexible-dosing of psilocybin assisted therapy in intermediate and high-risk patients will be delivered to reduce suicidal ideation and identify mediators of response. The study team will deliver two separate psilocybin sessions accompanied by preparation and integration therapy. Factors such as dose, depression severity, serotonergic use, and depth of mystical experiences will be correlated with suicidality reduction.",[21],null,{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":38},"BEHAVIORAL","Neurofeedback","This intervention will deliver active or sham real-time fMRI neurofeedback occurring across two visits to a low-to-intermediate risk population, i.e., low-to-severe levels of depression or anxiety\u002FPTSD identified by clinical scales, with suicidal ideation present but no intent or plan.",[9],[45],{"name":46,"affiliation":5,"role":47},"Davin Quinn, MD","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":38,"email":53},"Crystal A Garcia","CONTACT","505-272-9552","crabaca@salud.unm.edu",{"type":55,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[57,60],{"name":58,"class":59},"United States Department of Defense","FED",{"name":61,"class":6},"The Mind Research Network","100650222","phase-2-assessing-of-behavioral-risk-and-response-to-electromagnetic-and-psychedelic-therapies-100650222",false,"NCT07745569","Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies","Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies","PRE-EMPT","Inclusion Criteria:\n\n1. 18-69 years old\n2. Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation.\n3. Formal diagnosis of major depressive disorder or post-traumatic stress disorder by a mental health professional.\n4. Must be under the care of a medical provider (ex: primary care, therapist, psychiatrist, psychiatric nurse practitioner) for mental health treatment who can provide contact information and written confirmation that they will be willing and able to care for participant during their entire involvement in the study.\n\nExclusion Criteria:\n\n1. A prior history of other central nervous system disease or any history of seizures;\n2. history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I);\n3. history of current or recent (within one year) substance\u002Falcohol use disorder, with the exception of tobacco use disorder;\n4. meet criteria for Very High risk of suicide, or require inpatient hospital-level care for psychiatric reasons at time of consent, to reduce exacerbation of risk of harm to self during study;\n5. presence of any implanted metal or electrical device (e.g. pacemaker);\n6. recent medical hospitalization (within three weeks);\n7. any condition that would prevent the participant from completing the protocol, such as significant agitation;\n8. appointment of a legal representative or treatment guardian;\n9. any ongoing litigation related to a health condition;\n10. any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia;\n11. pregnancy or lactation;\n12. a family history of schizophrenia or schizoaffective disorder (first or second degree relatives), or bipolar disorder type 1 (first degree relatives), to reduce risk of exacerbation of an undiagnosed psychotic condition;\n13. other medical conditions that would preclude safe participation in the trial (e.g., decompensated heart failure);\n14. starting or planning to start psychotherapy or changing the frequency or intensity of existing psychotherapy during the trial (current psychotherapy can be continued provided the frequency and intensity has been stable for ≥2 months prior to screening);\n15. membership in a vulnerable population (minors, prisoners);\n16. any contraindication for blood draws.\n\nArm 1:\n\nInclusion:\n\n1. PRE-EMPT Risk Level Low or Intermediate (recent suicidal ideation, but no intent\u002Fplan; C-SSRS level low; mild-to-moderate depression (QIDS score 6-15) or PTSD (PCL-5 score 20-32))\n2. Right-handed.\n\nArm 2:\n\nInclusion:\n\n1\\) PRE-EMPT Risk Level Intermediate or High (recent suicidal ideation, but no intent or plan; C-SSRS level low to moderate; moderate to severe depression (QIDS score \\>16) or PTSD (PCL-5 score greater than or equal to 33))\n\nArm 3:\n\nInclusion:\n\n1\\) PRE-EMPT Risk Level Intermediate or High (recent suicidal ideation, but no intent or plan; C-SSRS level low to moderate; moderate to severe depression (QIDS score ≥16) or PTSD (PCL-5 score greater than or equal to 33))\n\nExclusions:\n\n1. Other additional medical conditions that would preclude safe participation in this arm of the trial:\n\n   1. significantly impaired liver function,\n   2. severe coronary artery disease,\n   3. heart failure,\n   4. uncontrolled hypertension (above 140\u002F90 mmHg upon screening) ,\n\n   i. If blood pressure is consistently elevated \\> 140\u002F90 mmHg across 3 attempts, subjects may be referred to their primary care provider for management of hypertension. Upon management of blood pressure, subjects will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a blood pressure reading ≤ 140\u002F90 mmHg. Subjects will be considered eligible upon registering 1 blood pressure reading ≤ 140\u002F90 mmHg during the screening period. Blood pressure will be reassessed on Day 0 prior to dosing, and must be less than or equal to 140 systolic, 90 diastolic, with resting pulse ≤ 100 (ascertained within 20 minutes of IP administration in order for the participant to receive study medication.) e. history of cerebrovascular accident, f. severe obesity (BMI ≥ 35), g. untreated asthma, h. untreated hyperthyroidism, i. narrow-angle glaucoma, j. stenosing peptic ulcer, k. pyloroduodenal obstruction, l. symptomatic prostatichypertrophy, or m. bladder-neck obstruction, n. history of valvular heart disease or any heart condition that affects the valves\n2. serious ECG abnormalities (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate \\[QTc\\] prolongation (QTc \\> 0.45 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia);\n3. allergy or hypersensitivity to psilocybin or chocolate","ALL","18 Years","69 Years",{"count":74,"type":75},150,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","PRE-EMPT will assemble a cohort of 150 participants from three populations (low risk, intermediate risk, and high risk for self-harm). We will obtain clinical assessments, structural and functional MRI utilizing tasks pioneered by our team to assess cognitive control (CC) and emotion regulation (ER), and peripheral circular RNA (circRNA) levels to characterize the molecular brain states associated with behavioral risk. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of our risk prediction models. PRE-EMPT in three separate Aims will then prospectively assess three promising and innovative interventions for their potential to reduce suicidal ideation and alter activity in key neural networks: 1) neurofeedback (NF) using real-time fMRI with simultaneous electroencephalography (EEG), 2) a form of transcranial magnetic stimulation (TMS) called accelerated intermittent theta burst stimulation (aiTBS) with dose optimization through electric field modeling; and 3) psilocybin assisted therapy (PSI), with flexible dosing plan to maximize the depth of psychedelic experience. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects.",[81,82,83,84],"PTSD","PTSD - Post Traumatic Stress Disorder","Major Depression","Suicidality",[32,86,87,88,89],"Transcranial magnetic stimulation","neuromodulation","psilocybin","neurofeedback","NOT_YET_RECRUITING","2026-07-29",{"date":93,"type":94},"2026-08-04","ACTUAL",{"date":96,"type":75},"2026-08-31",{"date":98,"type":75},"2030-06-30",{"name":5,"class":6}]