[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06580041":3,"trial-entities:NCT06580041":134,"trial-summary:NCT06580041":138},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":66,"secondary_outcomes":71,"sex":96,"minimum_age":97,"maximum_age":98,"healthy_volunteers":14,"eligibility_criteria":99,"std_ages":114,"locations":117,"central_contacts":127,"overall_officials":128,"references":132,"see_also_links":133},"NCT06580041","24-41815","Precision Care for Major Depressive Disorder","ENROLLING_BY_INVITATION","2029-09-01","2025-09","2025-09-05","2024-11-12","University of California, San Francisco","OTHER",false,"This study aims to assess whether phenotyping-guided intervention selection is superior to intervention selection without phenotyping guidance (i.e., routine clinician and patient judgment regarding treatment selection) for depression.","This study will classify patients seen in the Depression Clinic of the UCSF Department of Psychiatry and Behavioral Sciences into one of five phenotypes (subtypes), including: 1) Anhedonia, 2) Cognitive deficits, 3) Stress sensitivity, 4) Anxious distress, and 5) Grief.\n\nAfter phenotyping, participants will be randomized to receive phenotype-specific intervention (PSI) or care as usual (CAU).",[18,19,20],"Major Depressive Disorder","Depression","Depressive Disorder, Major",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},150,"ESTIMATED",[30,36,41,46,52,57],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Pramipexole","CAU plan modified to include a trial of pramipexole.",[35],"Anhedonia phenotype: PSI",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Methylphenidate","CAU plan modified to include a trial of methylphenidate (or, if contraindicated: guanfacine).",[40],"Cognitive deficits: PSI",{"type":31,"name":42,"description":43,"armGroupLabels":44},"Phenelzine","CAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole).",[45],"Anxious distress: PSI",{"type":47,"name":48,"description":49,"armGroupLabels":50},"BEHAVIORAL","Mindfulness-based Stress Sensitivity Therapy (MBSST)","CAU plan modified to include a trial of MBSST. MBSST is an individual psychotherapy delivered approximately weekly for 16 sessions.",[51],"Stress sensitivity: PSI",{"type":47,"name":53,"description":54,"armGroupLabels":55},"Complicated Grief Treatment (CGT)","CAU plan modified to include a trial of CGT.",[56],"Grief: PSI",{"type":13,"name":58,"description":59,"armGroupLabels":60},"Care as usual (CAU) plan","Unmodified CAU plan.",[61,62,63,64,65],"Anhedonia phenotype: CAU","Anxious distress: CAU","Cognitive deficits: CAU","Grief: CAU","Stress sensitivity: CAU",[67],{"measure":68,"description":69,"timeFrame":70},"Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score","Within-phenotype and across-phenotype contrasts.","Up to 24 weeks after randomization.",[72,75,78,80,83,86,88,90,93],{"measure":73,"description":74,"timeFrame":70},"Snaith-Hamilton Pleasure Scale (SHAPS) score","For anhedonia phenotype only.",{"measure":76,"description":77,"timeFrame":70},"Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score","For anxious distress phenotype only.",{"measure":79,"description":77,"timeFrame":70},"Generalized Anxiety Disorder 7-item (GAD-7) score",{"measure":81,"description":82,"timeFrame":70},"Inventory of Complicated Grief (ICG) score","For grief phenotype only.",{"measure":84,"description":85,"timeFrame":70},"Perceived Deficits Questionnaire - Depression (PDQ-D) score","For cognitive deficits phenotype only.",{"measure":87,"description":69,"timeFrame":70},"Patient Health Questionnaire - 8 (PHQ-8) score",{"measure":89,"description":69,"timeFrame":70},"WHO Disability Assessment Schedule (WHODAS 2.0)",{"measure":91,"description":92,"timeFrame":70},"Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response","50% reduction from baseline score. Within-phenotype and across-phenotype contrasts.",{"measure":94,"description":95,"timeFrame":70},"Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission","Score \\\u003C 6. Within-phenotype and across-phenotype contrasts.","ALL","18 Years",null,{"inclusion":100,"exclusion":108,"raw_text":113},[101,102,103,104,105,106,107],"Participant is able to provide informed consent","English speaker","18 years of age or older at time of consent","Meets DSM-5 criteria for Major Depressive Disorder","The subject meets eligibility criteria for at least one study phenotype as determined by assessments, imaging and\u002For clinical judgment.","PHQ-8 score at baseline of \\>= 10","Scheduled for or completed intake in UCSF outpatient psychiatry",[109,110,111,112],"Unstable or untreated medical or psychiatric condition based on clinical assessment by investigator(s)","Significant risk of suicidal or violent behavior as determined by clinical judgement","In the Investigators' opinion, the subject is not capable of adhering to the protocol requirements, or the subject has a history of poor or suspected poor compliance in clinical research studies, or the subject has a history of poor or suspected poor compliance to antidepressant medication or that study participation is not in their best interest (e.g., different treatment is indicated given their clinical presentation)","Pregnant or breastfeeding or planning to become pregnant during the study","Inclusion Criteria:\n\n* Participant is able to provide informed consent\n* English speaker\n* 18 years of age or older at time of consent\n* Meets DSM-5 criteria for Major Depressive Disorder\n* The subject meets eligibility criteria for at least one study phenotype as determined by assessments, imaging and\u002For clinical judgment.\n* PHQ-8 score at baseline of \\>= 10\n* Scheduled for or completed intake in UCSF outpatient psychiatry\n\nExclusion Criteria:\n\n* Unstable or untreated medical or psychiatric condition based on clinical assessment by investigator(s)\n* Significant risk of suicidal or violent behavior as determined by clinical judgement\n* In the Investigators' opinion, the subject is not capable of adhering to the protocol requirements, or the subject has a history of poor or suspected poor compliance in clinical research studies, or the subject has a history of poor or suspected poor compliance to antidepressant medication or that study participation is not in their best interest (e.g., different treatment is indicated given their clinical presentation)\n* Pregnant or breastfeeding or planning to become pregnant during the study",[115,116],"ADULT","OLDER_ADULT",[118],{"facility":119,"city":120,"state":121,"zip":122,"country":123,"geoPoint":124},"Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco","San Francisco","California","94107","United States",{"lat":125,"lon":126},37.77493,-122.41942,[],[129],{"name":130,"affiliation":12,"role":131},"Andrew D. Krystal, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":135,"biomarkers":137},[136],"Unipolar Depression",[],{"nct_id":4,"found":14,"summary":98,"prompt_version":98}]