PRIME Care (PRecision Medicine In MEntal Health Care)

Completed · Not applicable

Conditions studied: Major Depression

In brief

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.

Key facts

Study ID

NCT03170362

Run by

VA Office of Research and Development

People needed

1944

Starts

2017-06-15

Expected to finish

2022-03-31

Last updated by the study team

2024-05-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR — North Little Rock, Arkansas, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
• Wilmington VA Medical Center, Wilmington, DE — Wilmington, Delaware, United States
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
• VA Western New York Healthcare System, Buffalo, NY — Buffalo, New York, United States
• Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC — Salisbury, North Carolina, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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