Precision Care for Major Depressive Disorder

Phase 4

• Conditions: Major Depressive Disorder; Depression; Depressive Disorder, Major
• Interventions: Other: Care as usual (CAU) plan; Behavioral: Complicated Grief Treatment (CGT); Drug: Pramipexole; Drug: Methylphenidate; Behavioral: Mindfulness-based Stress Sensitivity Therapy (MBSST); Drug: Phenelzine

• Registration Number: NCT06580041
• Lead Sponsor: University of California, San Francisco

Brief 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).

Study Timeline

• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Study Start: 2024-11-12
• Primary Completion: 2029-09-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anxious distress: CAU	Care as usual (CAU) plan	-
Grief: PSI	Complicated Grief Treatment (CGT)	-
Grief: CAU	Care as usual (CAU) plan	-
Anhedonia phenotype: PSI	Pramipexole	-
Anhedonia phenotype: CAU	Care as usual (CAU) plan	-
Cognitive deficits: PSI	Methylphenidate	-
Cognitive deficits: CAU	Care as usual (CAU) plan	-
Stress sensitivity: PSI	Mindfulness-based Stress Sensitivity Therapy (MBSST)	-
Stress sensitivity: CAU	Care as usual (CAU) plan	-
Anxious distress: PSI	Phenelzine	-

Primary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score	Up to 24 weeks after randomization.	Within-phenotype and across-phenotype contrasts.

Secondary Outcome Measures

Name	Time	Method
Snaith-Hamilton Pleasure Scale (SHAPS) score	Up to 24 weeks after randomization.	For anhedonia phenotype only.
Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score	Up to 24 weeks after randomization.	For anxious distress phenotype only.
Generalized Anxiety Disorder 7-item (GAD-7) score	Up to 24 weeks after randomization.	For anxious distress phenotype only.
Inventory of Complicated Grief (ICG) score	Up to 24 weeks after randomization.	For grief phenotype only.
Perceived Deficits Questionnaire - Depression (PDQ-D) score	Up to 24 weeks after randomization.	For cognitive deficits phenotype only.
Patient Health Questionnaire - 8 (PHQ-8) score	Up to 24 weeks after randomization.	Within-phenotype and across-phenotype contrasts.
WHO Disability Assessment Schedule (WHODAS 2.0)	Up to 24 weeks after randomization.	Within-phenotype and across-phenotype contrasts.
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response	Up to 24 weeks after randomization.	50% reduction from baseline score. Within-phenotype and across-phenotype contrasts.
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission	Up to 24 weeks after randomization.	Score \< 6. Within-phenotype and across-phenotype contrasts.

Trial Locations

Locations (1)

Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco; 🇺🇸 San Francisco, California, United States