Major Depressive Disorder, Depression, Depressive Disorder, Major
Conditions
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).
Interventions
DRUGPramipexole
CAU plan modified to include a trial of pramipexole.
DRUGMethylphenidate
CAU plan modified to include a trial of methylphenidate (or, if contraindicated: guanfacine).
DRUGPhenelzine
CAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole).
BEHAVIORALMindfulness-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.
BEHAVIORALComplicated Grief Treatment (CGT)
CAU plan modified to include a trial of CGT.
OTHERCare as usual (CAU) plan
Unmodified CAU plan.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Snaith-Hamilton Pleasure Scale (SHAPS) score | Up to 24 weeks after randomization. | For anhedonia phenotype only. |
| 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. |
| Patient Health Questionnaire - 8 (PHQ-8) score | Up to 24 weeks after randomization. | Within-phenotype and across-phenotype contrasts. |
Countries
United States
Outcome results
None listed