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.
We propose a program of research to evaluate the utility of PGx testing in treating Major Depressive Disorder.
We 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)
The following patient inclusion and exclusion criteria will be used:
Patient Inclusion Criteria. a) age 18 to 80 years, inclusive; b) PHQ-9 score 10 and a presumptive diagnosis of MDD per PHQ-9 criteria; c) at least one prior treatment exposure for MDD (psychotherapy or antidepressant); d) intent to start treatment of the MDD with an antidepressant (simple dose increases will not be considered inclusionary), and e) willingness to provide signed, informed consent to participate in the study.
Patient Exclusion Criteria. a) current serious co-occurring psychiatric illness (i.e., schizophrenia, bipolar disorder, psychotic major depression, borderline or antisocial personality disorder, eating disorder; b) active alcohol or other drug use disorder; c) PTSD checklist (PCL-5) score > 39; d) current use of an antipsychotic medication; e) 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); f) patients requiring urgent care or inpatient hospitalization at the time of consent; or g) currently incarcerated.
None at this time, the project is recruiting at this time.
Despite such a compelling epidemiological imperative, the treatment of depression is often inadequate. As shown now in several studies, to achieve remission from depression, patients and providers must be persistent and try multiple treatments until they find one that is both tolerable and effective. However, with each round of treatment, there is greater attrition from treatment. Replication of the results from the limited PGx implementation studies that have been conducted to date could usher in a new era in the treatment of MDD and provide an impetus for early diagnosis and treatment, resulting in more rapid and higher rates of remission. No change in the impact.
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Mental, Cognitive and Behavioral Disorders, Substance Abuse and Addiction
Substance Use and Abuse