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Enrolling by invitation NCT06580041

Precision Care for Major Depressive Disorder

Phase IV Interventional Major Depressive Disorder Depression Depressive Disorder, Major

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pramipexole, Methylphenidate, Phenelzine, Mindfulness-based Stress Sensitivity Therapy (MBSST).
Who it may be relevant to
Registry conditions: Major Depressive Disorder, Depression, Depressive Disorder, Major. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

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.

Primary outcome measures

  • Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score [Time frame: Up to 24 weeks after randomization.]
Secondary outcome measures (9)
  • Snaith-Hamilton Pleasure Scale (SHAPS) score [Time frame: Up to 24 weeks after randomization.]
  • Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score [Time frame: Up to 24 weeks after randomization.]
  • Generalized Anxiety Disorder 7-item (GAD-7) score [Time frame: Up to 24 weeks after randomization.]
  • Inventory of Complicated Grief (ICG) score [Time frame: Up to 24 weeks after randomization.]
  • Perceived Deficits Questionnaire - Depression (PDQ-D) score [Time frame: Up to 24 weeks after randomization.]
  • Patient Health Questionnaire - 8 (PHQ-8) score [Time frame: Up to 24 weeks after randomization.]
  • WHO Disability Assessment Schedule (WHODAS 2.0) [Time frame: Up to 24 weeks after randomization.]
  • Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response [Time frame: Up to 24 weeks after randomization.]
  • Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission [Time frame: Up to 24 weeks after randomization.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco — San Francisco

Identifiers

NCT: NCT06580041 · 24-41815

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗