Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans

Auburn University

Status: Withdrawn

Conditions: Medication Therapy Management; Depressive Disorder, Major; Pharmacogenetics

Treatments: Other: Pharmacogenomic Screening

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04893395

TVA_IRBNetID_1614352

Details and patient eligibility

About

The purpose of this study is to assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic variation that impacts the safety or efficacy of the subject medication.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 19 years
2. Prescribed at least one chronic medication for mental health which is considered pharmacogenomically actionable, as defined above (amitriptyline, doxepin, imipramine, nortriptyline, citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, or venlafaxine).
3. Diagnosis of major depressive disorder (MDD)

Exclusion criteria

1. Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration
2. Persistent medication non-adherence for reasons not potentially linked to pharmacogenomic variation (e.g. inability to obtain medications due to cost; non-adherence due to cognitive impairment)
3. Individuals receiving mental health treatment/care from a non-VA facility
4. Individuals who are terminally ill
5. Inability to communicate in and/or understand English

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Pharmacogenomic Screening

Experimental group

Description:

Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.

Treatment:

Other: Pharmacogenomic Screening