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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacogenetics Depressive Disorder, Major Medication Therapy Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Pharmacogenomic Screening

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

Group Type EXPERIMENTAL

Pharmacogenomic Screening

Intervention Type OTHER

First telehealth appointment:

1. Pharmacogenomics education and informed consent
2. Medical history
3. Sample collection

Second telehealth appointment:

1. Results of pharmacogenomic testing
2. Utility and limitations of pharmacogenomic testing
3. Patient-specific potential impacts on current or future medication therapies
4. Answering of patient questions
5. Referral to mental health provider(s) for treatment-specific recommendations

Interventions

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Pharmacogenomic Screening

First telehealth appointment:

1. Pharmacogenomics education and informed consent
2. Medical history
3. Sample collection

Second telehealth appointment:

1. Results of pharmacogenomic testing
2. Utility and limitations of pharmacogenomic testing
3. Patient-specific potential impacts on current or future medication therapies
4. Answering of patient questions
5. Referral to mental health provider(s) for treatment-specific recommendations

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No