Clinical trial NCT06580041: Precision Care for Major Depressive Disorder
Official title: Precision Care for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Major Depressive Disorder
Depression
Depressive Disorder, Major
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score
timeFrame: Up to 24 weeks after randomization.
Secondary outcomes:
measure: Snaith-Hamilton Pleasure Scale (SHAPS) score
timeFrame: Up to 24 weeks after randomization.
measure: Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score
timeFrame: Up to 24 weeks after randomization.
measure: Generalized Anxiety Disorder 7-item (GAD-7) score
timeFrame: Up to 24 weeks after randomization.
measure: Inventory of Complicated Grief (ICG) score
timeFrame: Up to 24 weeks after randomization.
measure: Perceived Deficits Questionnaire - Depression (PDQ-D) score
timeFrame: Up to 24 weeks after randomization.
measure: Patient Health Questionnaire - 8 (PHQ-8) score
timeFrame: Up to 24 weeks after randomization.
measure: WHO Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Up to 24 weeks after randomization.
measure: Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response
timeFrame: Up to 24 weeks after randomization.
measure: Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission
timeFrame: Up to 24 weeks after randomization.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Andrew D. Krystal, MD
role: PRINCIPAL_INVESTIGATOR
References: