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Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population

NCT03468309 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2024-04-23

Study results available
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Summary

Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects. Pharmacogenetic assays, such as the Genecept® Assay, have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. Thus, this study is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing and a computerized decision tool for providers to determine the potential efficacy of the assay to reduce polypharmacy and improve patient outcomes.

Conditions

  • Pharmacogenetic Testing

Interventions

GENETIC

Genecept Assay and G-DIG decision tool

Participating providers will review results of the Genecept Assay using a secure web-based program and will utilize the G-DIG tool in order to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.

Sponsors & Collaborators

  • Genomind, LLC

    collaborator INDUSTRY

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Amanda E Wood, PhD. · VA Puget Sound Health Care System

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-04-01
Completion
2024-04-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468309 on ClinicalTrials.gov