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PRIME Care (PRecision Medicine In MEntal Health Care)

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03170362
Collaborator
(none)
1,944
Enrollment
24
Locations
2
Arms
57.5
Actual Duration (Months)
81
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The focus of this application is on the impact of providing depressed Veterans and their providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The project focuses on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat Major Depressive Disorder (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of functional impairment and mortality. Validation of a PGx test to personalize the treatment of MDD represents an important opportunity to improve the healthcare of Veterans.

Condition or Disease Intervention/Treatment Phase
  • Other: Pharmacogenetic Test
 N/A

Detailed Description

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:

  1. 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)

  2. Provider/patient dyads in the intervention group will use fewer medications that have potential gene-drug interactions based on commercial PGx test results than dyads in the delayed results group (Primary Hypothesis).

Study Design

Study Type:
Interventional
Actual Enrollment :
1944 participants
Allocation:
Randomized
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.The study intervention is the provision of pharmacogenetic test results which can then be used to choice appropriate medication.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
PRIME Care (PRecision Medicine In MEntal Health Care)
Actual Study Start Date :
Jun 15, 2017
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

  1. Depression Remission [24 weeks post randomization]

    The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity.

  2. Use of fewer medications that have potential gene-drug interactions [Over the first 30 days]

    The investigators will examine the proportion of antidepressants used that have the potential for gene-drug interactions.

Secondary Outcome Measures

  1. Antidepressant side effects [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

  2. VR -12 - Quality of life measure [24 weeks]

    The investigators will use the VR-12 as a self reported quality of life measure.

  3. Antidepressant prescription availability [24 weeks]

    We will examine the availability of antidepressants by creating a possession ratio of the number of days that a prescription was filled and available to the Veteran.

  4. Depression severity [24 Weeks]

    The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. This measure will use the PHQ9 as a continuous measure.

  5. Depression response [24 weeks]

    The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Remission will be measured by a 50% reduction in scores from baseline to each time point.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • PHQ-9 score 10 and a presumptive diagnosis of MDD per PHQ-9 criteria

  • at least one prior treatment exposure for MDD (psychotherapy or antidepressant

  • intent to start treatment of the MDD with an antidepressant, simple dose increases will not be considered inclusionary

  • willingness to provide signed, informed consent to participate in the study

Exclusion Criteria:

  • current serious co-occurring psychiatric illness, i.e.:

  • schizophrenia

  • bipolar disorder

  • psychotic major depression

  • borderline or antisocial personality disorder

  • eating disorder

  • active alcohol or other drug use disorder

  • current use of an antipsychotic medication

  • augmentation therapy, e.g.:

  • use of two or more antidepressants at the time of randomization (trazodone at a dosage < 150 mg/day will not be considered augmentation and thus allowed)

  • patients requiring urgent care or inpatient hospitalization at the time of consent

  • currently incarcerated

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR North Little Rock Arkansas United States 72114-1706
2 VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California United States 94304-1290
3 San Francisco VA Medical Center, San Francisco, CA San Francisco California United States 94121
4 VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California United States 90073
5 Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado United States 80045
6 VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut United States 06516
7 Wilmington VA Medical Center, Wilmington, DE Wilmington Delaware United States 19805
8 Miami VA Healthcare System, Miami, FL Miami Florida United States 33125
9 Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland United States 21201
10 VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts United States 02130
11 VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan United States 48105
12 Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota United States 55417
13 New Mexico VA Health Care System, Albuquerque, NM Albuquerque New Mexico United States 87108-5153
14 VA Western New York Healthcare System, Buffalo, NY Buffalo New York United States 14215
15 Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC Salisbury North Carolina United States 28144
16 Cincinnati VA Medical Center, Cincinnati, OH Cincinnati Ohio United States 45220
17 Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio United States 44106
18 Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Philadelphia Pennsylvania United States 19104
19 VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania United States 15240
20 Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina United States 29401-5799
21 Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas United States 77030
22 VA Salt Lake City Health Care System, Salt Lake City, UT Salt Lake City Utah United States 84148
23 Hunter Holmes McGuire VA Medical Center, Richmond, VA Richmond Virginia United States 23249
24 VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington United States 98108

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: David W. Oslin, MD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03170362
Other Study ID Numbers:
  • SDR 16-348
First Posted:
May 31, 2017
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Treatment
Pharmacogenetics
Depression
Additional relevant MeSH terms:
Depression

Study Results

No Results Posted as of Apr 21, 2022