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Precision Care for Major Depressive Disorder

NCT06580041 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Andrew D. Krystal, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2029-09-01
Completion
2029-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580041 on ClinicalTrials.gov