PRIME Care (PRecision Medicine In MEntal Health Care) 2.0

NCT04958824 | Unknown Phase 4

• 1 other identifier: 01847
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Pharmacogenetics

Outcome Measures

Primary Outcomes (2)

• Polypharmacy

  The main outcome will be a reduction in the number of psychotropic medications prescribed.

  12 weeks

• Symptoms of distress

  Veterans in the intervention group will have lower levels of distress than the control condition.

  12 weeks.

Secondary Outcomes (1)

• Adverse effects

  12 weeks.

Study Arms (2)

Immediate return of results

EXPERIMENTAL

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.

Diagnostic Test: Pharmacogenetic test

Delayed return of results

NO INTERVENTION

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

Interventions

Pharmacogenetic test DIAGNOSTIC_TEST

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

Immediate return of results

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Corporal Michael J. Crescenz VA Medical Center: lead

Study Sites (1)

Cpl Michael J Crescenz VAMC

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• David Oslin, MD

  Cpl Michael J Crescenz VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Oslin, MD

CONTACT

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

Erin Ingram

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ACOS Behavioral Health

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: June 2, 2020
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2024
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)