PRIME Care (PRecision Medicine In MEntal Health Care)

Status:	Enrolling by invitation
Conditions:	Depression, Major Depression Disorder (MDD)
Therapuetic Areas:	Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 80
Updated:	12/22/2018
Start Date:	June 15, 2017
End Date:	March 31, 2022

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.

Background: In the last several years, commercial pharmacogenetic (PGx) testing for
psychotropic medications has become widespread as a means of implementing "precision
medicine", with some insurers electing to cover the cost of testing. These developments have
put increasing pressure on the Veterans Health Administration to implement a mental health
focused PGxs program, especially for treating depression, but without sufficient scientific
study to support the utility of clinical application.

Objectives: The investigators propose a program of research to evaluate the utility of PGx
testing in treating Major Depressive Disorder.

Methods: The investigators plan a multi-site RCT (n=2000), patient/provider dyads will be
randomly assigned to receive results of the PGx battery right after randomization (i.e.
intervention group) or after 6 months of treatment as usual (i.e. delayed results group)The
study will test the following hypotheses:

1. Veterans with MDD whose care is guided by the results of the PGx battery (the
intervention group) will have a higher rate of remission of depression than the delayed
results group. (Primary Hypothesis)

2. Provider/patient dyads in the intervention group will use fewer contraindicated
medications based on established PGx criteria than the delayed results group. (Primary
Hypothesis)

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

- PTSD checklist (PCL-5) score > 39

- 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

We found this trial at

sites

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

3900 Woodland Avenue
Philadelphia, Pennsylvania 19104

from

Philadelphia, PA