Recruiting

Precision Medicine

Sponsor:

Corporal Michael J. Crescenz VA Medical Center

Code:

NCT04958824

Conditions

Psychiatric or Mood Diseases or Conditions

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pharmacogenetic test

Study Details

Brief summary:

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.

Conditions

Psychiatric or Mood Diseases or Conditions

Study ID

NCT04958824

Start date

Jun 2, 2020

Status verified date

Jul, 2021

Completion date

Jul 30, 2024

Anticipated

Primary completion date

Jul 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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).

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate return of results

The intervention for this study is the delivery of genetic test results that reflect pharmacokinetic and pharmacodynamic effects of specified genetic markers. We will use the Sanford panel being promoted by the VA through a clinical project entitled PHASER. The results are returned to the patient and provider approximately 1 week from randomization.

no intervention: Delayed return of results

In the control arm the genetic test results are not returned until 12 weeks when the main outcome is assessed.

Interventions

Pharmacogenetic test

Pharmacogenetic test results for Cytochrome P450 genes are examined for markers of variant metabolism.

Primary outcome measure

  • Polypharmacy [ Time Frame: 12 weeks ]
  • Symptoms of distress [ Time Frame: 12 weeks. ]

Central Contacts and Locations

Central contacts

David Oslin, MD

215-823-5894dave.oslin@va.gov

Erin Ingram

215-823-5800erin.ingram@va.gov

Locations

Cpl Michael J Crescenz VAMC

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

David Oslin, MD

215-823-5894dave.oslin@va.gov

More Information

Sponsor

Corporal Michael J. Crescenz VA Medical Center

Last update posted

Jul 12, 2021

Last verified

Jul, 2021

Keywords

  • Pharmacogenetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corporal Michael J. Crescenz VA Medical Center on 2021-07-12.