[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649718":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":40,"centralContacts":41,"locations":40,"responsibleParty":47,"collaborators":40,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":40,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":40,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":76,"whyStopped":40,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":40},{"fullName":5,"class":6},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pharmacogenomics-Guided Antidepressant Therapy","EXPERIMENTAL","Patients receive pharmacogenomic testing via buccal swab at baseline. The test detects polymorphisms in CYP2D6, CYP2C19, CYP3A4\u002F5, CYP1A2, CYP2B6, CYP2C9, HTR2A, and SLC6A4. Clinicians select antidepressant type and starting dosage based on the genotype report (metabolizer phenotype) to optimize efficacy and minimize adverse drug reactions.",[13],"Diagnostic Test: Pharmacogenomic Testing",{"label":15,"type":16,"description":17,"interventionNames":18},"Guideline-Based Conventional Antidepressant Therapy","ACTIVE_COMPARATOR","Patients undergo a sham buccal swab procedure without genetic analysis. Clinicians prescribe antidepressants following the Chinese Depression Prevention and Treatment Guidelines, based on clinical experience, symptom profiles, prior medication history, and physical condition. Medication adjustments are allowed during the 12-week follow-up.",[19],"Drug: Antidepressant Agents",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Pharmacogenomic Testing","Buccal swab collection for targeted genotyping of polymorphisms in CYP2D6, CYP2C19, CYP3A4\u002F5, CYP1A2, CYP2B6, CYP2C9, HTR2A, and SLC6A4. The assay classifies patients into ultrarapid, normal, intermediate, or poor metabolizer phenotypes for CYP450 enzymes, and provides response\u002Frisk predictions for SSRIs (escitalopram, sertraline, fluoxetine, paroxetine, fluvoxamine, citalopram), SNRIs (venlafaxine, duloxetine, milnacipran), mirtazapine, and bupropion. A written report with genotype-based drug and dosage recommendations is issued to the clinician.",[9],[27,28,29],"PGx Genotyping","CYP450 Genotyping Panel","Antidepressant Genetic Test",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Antidepressant Agents","Oral administration of first-line or second-line antidepressants approved for major depressive disorder, including selective serotonin reuptake inhibitors (SSRIs: escitalopram, sertraline, fluoxetine, paroxetine, fluvoxamine, citalopram), serotonin-norepinephrine reuptake inhibitors (SNRIs: venlafaxine, duloxetine, milnacipran), noradrenergic and specific serotonergic antidepressants (NaSSA: mirtazapine), and bupropion. Dosing follows clinical guidelines. In the experimental arm, selection and initial dosage are guided by the pharmacogenomic test report; in the conventional arm, selection and dosage are determined by physician expertise and standard care guidelines. Dose adjustments are permitted at Weeks 4, 8, and 12 based on efficacy and tolerability.",[15],[36,37,38,39],"SSRIs","SNRIs","Mirtazapine","Bupropion",null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Haiyan XIE, MD","CONTACT","+86 0579-89935006","8015138@zju.edu.cn",{"type":48,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100649718","biomarkers-and-pharmacogenomics-for-precision-depression-therapy-100649718",false,"NCT07738497","Biomarkers and Pharmacogenomics for Precision Depression Therapy","Study on Multidimensional Biomarkers of Depression and Individualized Therapy Based on Pharmacogenomic Technology","Inclusion Criteria:\n\n1. Clinical diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria\n2. Age between 18 and 60 years\n3. Baseline HAMD-17 total score ≥ 17\n4. Ability to provide written informed consent\n\nExclusion Criteria:\n\n1. History of other psychiatric disorders (e.g., bipolar disorder, schizophrenia)\n2. Presence of severe physical illnesses or major central nervous system diseases\n3. History of sedative-hypnotic, alcohol, or substance abuse\n4. Pregnancy, lactation, or planning to become pregnant during the study\n5. Significant abnormalities in ECG, complete blood count, or liver\u002Fkidney\u002Fthyroid function tests",true,"ALL","14 Years","60 Years",{"count":61,"type":62},220,"ESTIMATED","INTERVENTIONAL",[65],"NA","Background: The clinical management of major depressive disorder (MDD) is hampered by the lack of objective biomarkers and high inter-individual variability in drug response, with conventional antidepressants achieving only a 50% response rate.\n\nObjective and Design: This prospective, randomized, parallel-controlled trial aims to enroll 220 MDD patients, who will be allocated 1:1 to either a pharmacogenomics (PGx)-guided therapy group (treatment selection based on genetic testing) or a conventional treatment group (treatment as usual per guidelines), with a 12-week follow-up. Additionally, a matched healthy control cohort will be included for cross-sectional biomarker comparisons.\n\nIntervention and Outcomes: Patients in the PGx group undergo buccal swab testing for key genetic polymorphisms (e.g., CYP2D6, CYP2C19) to inform antidepressant type and dosage. The primary outcome is the 12-week response rate (≥50% reduction in HAMD-17 score from baseline). Secondary outcomes include remission rate, incidence of adverse drug reactions, and medication adjustment frequency.\n\nExploratory Aims: Multidimensional baseline data-including resting-state fMRI (VMHC), peripheral blood biomarkers (inflammatory cytokines, thyroid function, BDNF), urinary metabolites, and gut microbiome-will be integrated to construct a predictive model for treatment efficacy and to identify novel MDD biomarkers.\n\nScientific Significance: This study seeks to validate the clinical utility of PGx-guided prescribing and to advance the shift from symptom-based diagnosis towards a biological-characteristic-based precision medicine framework for depression.",[68],"Depression \u002F Major Depressive Disorder",[70,71,72,73,74,75],"Pharmacogenetics","Personalized Medicine","Biomarkers","Inflammation","Antidepressive Agents","Magnetic Resonance Imaging","NOT_YET_RECRUITING","2026-07-29",{"date":79,"type":80},"2026-07-31","ACTUAL",{"date":82,"type":62},"2026-07-01",{"date":84,"type":62},"2029-01-19",{"name":5,"class":6}]