PRIME Care (PRecision Medicine In MEntal Health Care) 2.0
Status unconfirmed · Phase 4
Conditions studied: Psychiatric or Mood Diseases or Conditions
In brief
Background: In the last several years, commercial pharmacogenetic (PGx) testing for the selection of psychotropic medications has become widespread as a means of implementing "precision medicine", with some insurers electing to cover the cost of testing. Mostly these efforts have focused on the decision of choosing a medication. Polypharmacy has become widespread and often the norm in patients with more severe of chronic illness. Objectives: This project is designed to evaluate the utility of PGx testing in reducing polypharmacy among Veterans with mental illness. Methods: The project is a randomized clinical trial in which 500 Veterans will be randomly assigned to have the results of the PGx battery available to clinical staff right after randomization (i.e., the intervention group) or after 3 months of treatment as usual (i.e., the delayed results group). The study will test the following primary hypotheses: 1. Veterans with psychiatric illness and currently receiving an antidepressant and at least one additional psychotropic medication whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of reduction in polypharmacy than those in the delayed results group. 2. Veterans whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of improvement in depressive symptoms (PHQ-9 score) than the delayed results group.
Key facts
- Study ID
- NCT04958824
- Run by
- Corporal Michael J. Crescenz VA Medical Center
- People needed
- 500
- Starts
- 2020-06-02
- Expected to finish
- 2024-07-30
- Last updated by the study team
- 2021-07-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a) age 18 to 80 years, inclusive; b) PHQ-9 score >9; c) currently prescribed at least one antidepressant from the Sanford PGx panel and at least one other psychotropic medication from the following medication classes; antidepressants, antipsychotics, "mood stabilizers," addiction medications, or benzodiazepines. Medications intended for short term use (<2 months) will not be counted. As needed medications (PRNs) taken at least 5 days a week for more than 2 months will count; d) willingness to give a blood sample for PGx testing; e) eligible for the PHASER test per current PHASER guidance; and e) willingness to provide signed, informed consent to participate in the study
You may not qualify if…
- Exclusion Criteria. a) current psychotic illness (e.g. schizophrenia, psychotic depression) per chart review; and b) inpatient hospitalization at the time of randomization (we will allow consent to occur during hospitalization, but the patient will need to return after hospitalization so that baseline measures do not reflect the patient status during a crisis).
Where it is running
- Cpl Michael J Crescenz VAMC — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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