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Enrolling by Invitation

NCT Number: NCT06580041

Precision Care for Major Depressive Disorder

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco

San Francisco, California, 94107, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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/or clinical judgment.
  • PHQ-8 score at baseline of >= 10
  • Scheduled for or completed intake in UCSF outpatient psychiatry

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score

    Time frame: Up to 24 weeks after randomization.

    Within-phenotype and across-phenotype contrasts.

Secondary outcomes

  1. Snaith-Hamilton Pleasure Scale (SHAPS) score

    Time frame: Up to 24 weeks after randomization.

    For anhedonia phenotype only.

  2. Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score

    Time frame: Up to 24 weeks after randomization.

    For anxious distress phenotype only.

  3. Generalized Anxiety Disorder 7-item (GAD-7) score

    Time frame: Up to 24 weeks after randomization.

    For anxious distress phenotype only.

  4. Inventory of Complicated Grief (ICG) score

    Time frame: Up to 24 weeks after randomization.

    For grief phenotype only.

  5. Perceived Deficits Questionnaire - Depression (PDQ-D) score

    Time frame: Up to 24 weeks after randomization.

    For cognitive deficits phenotype only.

  6. Patient Health Questionnaire - 8 (PHQ-8) score

    Time frame: Up to 24 weeks after randomization.

    Within-phenotype and across-phenotype contrasts.

  7. WHO Disability Assessment Schedule (WHODAS 2.0)

    Time frame: Up to 24 weeks after randomization.

    Within-phenotype and across-phenotype contrasts.

  8. Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response

    Time frame: Up to 24 weeks after randomization.

    50% reduction from baseline score. Within-phenotype and across-phenotype contrasts.

  9. Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission

    Time frame: Up to 24 weeks after randomization.

    Score < 6. Within-phenotype and across-phenotype contrasts.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 30, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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