At a glance
ClinicalIndex Comparison Record- ✓PHQ-9 score ≥10 with presumptive major depressive disorder diagnosis per PHQ-9 criteria
- ✓At least one prior treatment exposure for MDD (psychotherapy or antidepressant)
- ✓Intent to start treatment of MDD with an antidepressant (simple dose increases do not qualify)
- ✓Willing to provide signed informed consent
- ✕Current serious co-occurring psychiatric illness including schizophrenia, bipolar disorder, psychotic major depression, borderline or antisocial personality disorder, or eating disorder
- ✕Active alcohol or other drug use disorder
- ✕Current use of antipsychotic medication
- ✕Augmentation therapy (≥2 antidepressants; trazodone <150 mg/day allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PRIME Care (PRecision Medicine In MEntal Health Care)
In Brief
A clinical study evaluating Pharmacogenetic Test for Major Depression. Completed, enrolled 1,944 participants across 24 sites.
Detailed Summary
The focus of this application is on the impact of providing depressed Veterans and their providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The project focuses on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat Major Depressive Disorder (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of functional impairment and mortality. Validation of a PGx test to personalize the treatment of MDD represents an important opportunity to improve the healthcare of Veterans.
Study Details
Timeline
Interventions
The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.