NCT06580041

Precision Care for Major Depressive Disorder

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. After phenotyping, participants will be randomized to receive phenotype-specific intervention (PSI) or care as usual (CAU).

Conditions

• Major Depressive Disorder
• Depression
• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Pramipexole	CAU plan modified to include a trial of pramipexole.
DRUG	Methylphenidate	CAU plan modified to include a trial of methylphenidate (or, if contraindicated: guanfacine).
DRUG	Phenelzine	CAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole).
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.
BEHAVIORAL	Complicated Grief Treatment (CGT)	CAU plan modified to include a trial of CGT.
OTHER	Care as usual (CAU) plan	Unmodified CAU plan.

Timeline

• Start date: 2024-11-12
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2024-08-30
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study