← Back to Search

Pharmacogenetic Test for Mental Health Disorders (PRIME Care 2 Trial)

Phase 4
Recruiting
Led By David Oslin, MD
Research Sponsored by Corporal Michael J. Crescenz VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age between 18 to 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

PRIME Care 2 Trial Summary

This trial is designed to see if PGx testing can help reduce polypharmacy (use of multiple medications) among Veterans with mental illness.

Who is the study for?
This trial is for Veterans aged 18-80 with mental health disorders, taking at least one antidepressant and another psychotropic medication regularly. They must have a moderate level of depressive symptoms (PHQ-9 score >9) and be willing to provide a blood sample for pharmacogenetic testing.Check my eligibility
What is being tested?
The PRIME Care 2.0 trial tests if using pharmacogenetic testing can reduce the number of different medications (polypharmacy) in Veterans with mental illness, and improve depression symptoms compared to usual treatment without immediate test results.See study design
What are the potential side effects?
Since this trial involves genetic testing rather than drug intervention, there are no direct side effects from the test itself. However, changes in medication based on test results could lead to new or different side effects.

PRIME Care 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
- You are between 18 and 80 years old. - You have a score of more than 9 on the PHQ-9 questionnaire. - You are currently taking at least one antidepressant from the Sanford PGx panel and at least one other medication for mental health conditions such as antidepressants, antipsychotics, "mood stabilizers," addiction medications, or benzodiazepines. Medications taken for less than 2 months will not count. - You agree to give a blood sample for genetic testing. - You meet the requirements for the PHASER test according to current guidance. - You agree to give informed consent to participate in the study.
Select...
I am between 18 and 80 years old.

PRIME Care 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Polypharmacy
Symptoms of distress
Secondary outcome measures
Adverse effects

PRIME Care 2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate return of resultsExperimental Treatment1 Intervention
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.
Group II: Delayed return of resultsActive Control1 Intervention
In the control arm the genetic test results are not returned until 12 weeks when the main outcome is assessed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pharmacogenetic test
2020
N/A
~150

Find a Location

Who is running the clinical trial?

Corporal Michael J. Crescenz VA Medical CenterLead Sponsor
30 Previous Clinical Trials
10,016 Total Patients Enrolled
David Oslin, MDPrincipal InvestigatorCpl Michael J Crescenz VAMC
3 Previous Clinical Trials
4,264 Total Patients Enrolled

Media Library

Pharmacogenetic test Clinical Trial Eligibility Overview. Trial Name: NCT04958824 — Phase 4
Mental Health Disorders Research Study Groups: Immediate return of results, Delayed return of results
Mental Health Disorders Clinical Trial 2023: Pharmacogenetic test Highlights & Side Effects. Trial Name: NCT04958824 — Phase 4
Pharmacogenetic test 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958824 — Phase 4
Mental Health Disorders Patient Testimony for trial: Trial Name: NCT04958824 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants aged 85 or older?

"This study is open to those within the 18-80 age range."

Answered by AI

How many participants are currently enrolled in this research study?

"Affirmative. The information posted on clinicaltrials.gov testifies that this medical trial is presently in search of participants. It was first advertised on June 2nd, 2020 and the last update came through July 6th 2021 with a demand for 500 patients to be recruited from one site."

Answered by AI

Are there any openings for participants in this medical research?

"Confirming the details on clinicaltrials.gov, this medicinal experiment is still recruiting patients. It was initially released to the public on June 2nd 2020 and has been modified as recenty as July 6th 2021."

Answered by AI

To whom is the opportunity to participate in this experiment available?

"To apply for this medical research, potential participants must have a psychiatric or mood-related disorder and be aged between 18 to 80. To date, approximately 500 individuals have been accepted into the study."

Answered by AI

Has the FDA authorized Pharmacogenetic testing?

"The safety of pharmacogenetic testing has been well established, so it was awarded a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Maryland
How old are they?
65+
What site did they apply to?
Cpl Michael J Crescenz VAMC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to try different things to help my mental disorder.
PatientReceived 2+ prior treatments
~105 spots leftby Mar 2025