N/A
N=1,944
PRIME Care (PRecision Medicine In MEntal Health Care)
Major Depression
Bottom Line
View on ClinicalTrials.gov: NCT03170362 ↗Enrolled (actual)
1,944
Serious AEs
7.5%
Results posted
May 2024
Primary outcome: Primary: Depression Remission — 130; 126 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacogenetic Test (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Remission |
130; 126 | — |
| PRIMARY Use of Fewer Medications That Have Potential Gene-drug Interactions |
239; 299; 433; 173; 215; 373 | — |
| SECONDARY Depression Severity |
5.4; 4.8 | — |
| SECONDARY Depression Response |
242; 216 | — |
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.
Eligibility Criteria
Inclusion Criteria
- PHQ-9 score 10 and a presumptive diagnosis of MDD per PHQ-9 criteria
- at least one prior treatment exposure for MDD (psychotherapy or antidepressant
- intent to start treatment of the MDD with an antidepressant, simple dose increases will not be considered inclusionary
- willingness to provide signed, informed consent to participate in the study
Exclusion Criteria
- current serious co-occurring psychiatric illness, i.e.:
- schizophrenia
- bipolar disorder
- psychotic major depression
- borderline or antisocial personality disorder
- eating disorder
- active alcohol or other drug use disorder
- current use of an antipsychotic medication
- augmentation therapy, e.g.:
- use of two or more antidepressants at the time of randomization (trazodone at a dosage < 150 mg/day will not be considered augmentation and thus allowed)
- patients requiring urgent care or inpatient hospitalization at the time of consent
- currently incarcerated
Data sourced from ClinicalTrials.gov (NCT03170362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.