Precision Care for Major Depressive Disorder

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06580041
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pramipexole — DRUG
    CAU plan modified to include a trial of pramipexole.
  • Methylphenidate — DRUG
    CAU plan modified to include a trial of methylphenidate (or, if contraindicated: guanfacine).
  • Phenelzine — DRUG
    CAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole).
  • Mindfulness-based Stress Sensitivity Therapy (MBSST) — BEHAVIORAL
    CAU plan modified to include a trial of MBSST. MBSST is an individual psychotherapy delivered approximately weekly for 16 sessions.
  • Complicated Grief Treatment (CGT) — BEHAVIORAL
    CAU plan modified to include a trial of CGT.
  • Care as usual (CAU) plan — OTHER
    Unmodified CAU plan.

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Sep 2025
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anhedonia phenotype: PSI
  • Active Comparator: Anhedonia phenotype: CAU
  • Experimental: Cognitive deficits: PSI
  • Active Comparator: Cognitive deficits: CAU
  • Experimental: Stress sensitivity: PSI
  • Active Comparator: Stress sensitivity: CAU
  • Experimental: Anxious distress: PSI
  • Active Comparator: Anxious distress: CAU
  • Experimental: Grief: PSI
  • Active Comparator: Grief: CAU

Primary Outcome Measure

Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score [ Time Frame: Up to 24 weeks after randomization. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nancy Friend Pritzker Psychiatry Building, University of California, San FranciscoSan FranciscoCalifornia94107-

Find similar trials in San Francisco, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco· San Francisco, CA

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