PRIME Care (PRecision Medicine In MEntal Health Care) (PRIME Care)
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|ClinicalTrials.gov Identifier: NCT03170362|
Recruitment Status : Enrolling by invitation
First Posted : May 31, 2017
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Other: Pharmacogenetic Test||Not Applicable|
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:
- 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)
- Provider/patient dyads in the intervention group will use fewer contraindicated medications based on established PGx criteria than the delayed results group. (Primary Hypothesis)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study intervention is the provision of pharmacogenetic test results which can then be used to choice appropriate medication.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||PRIME Care (PRecision Medicine In MEntal Health Care)|
|Actual Study Start Date :||June 15, 2017|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Intervention group
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Other: Pharmacogenetic Test
The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
No Intervention: Delay results group
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
- Depression Severity [ Time Frame: 24 weeks post randomization ]The investigators will use the PHQ9 as a self assessed marker of depression severity.
- Use of recommended medications [ Time Frame: Over the 24 week period ]The investigators will examine the proportion of antidepressants used that conform to the recommendations from the pharmacogenetic testing. Medication dose and selection will be considered in determining if a proscription conforms to the recommendation of the testing.
- Self-reported antidepressant side effects [ Time Frame: over the 24 weeks ]Self reported assessment of side effects related to antidepressants. Specific questions about nausea, headache, vomiting, GI distress, and sexual dysfunction. Each item rated as not present, mild, moderate, severe
- VR -12 - Quality of life measure [ Time Frame: 24 weeks ]The investigators will use the VR-12 as a self reported quality of life measure.
- Provider attitudes [ Time Frame: baseline and 24 weeks ]This is a provider assessment of knowledge and attitudes regarding pharmacogenetic testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170362
|Principal Investigator:||David W. Oslin, MD||Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA|