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

NCT03468309 | Completed Results

• 1 other identifier: 01600
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

polypharmacy; drug interactions; DNA testing; mental health diagnosis; drug side effects; presciption treatment plans; mental health medication treatment plans

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression

  Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.

  Baseline and 12-weeks

Secondary Outcomes (3)

• Number of Psychiatric Medications

  Change from baseline to 12-weeks

• Patient Health Questionnaire-9 (PHQ-9)

  Change from baseline to 12-weeks

• Generalized Anxiety Scale-7 (GAD-7)

  Change from baseline to 12-weeks

Study Arms (1)

Genecept Assay and G-DIG decision tool

Veterans who have been prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another medication for side effects related to a medication prescribed for the mental health diagnosis.

Genetic: Genecept Assay and G-DIG decision tool

Interventions

Genecept Assay and G-DIG decision tool GENETIC

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.

Genecept Assay and G-DIG decision tool

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject pool will be drawn from Veterans receiving care at VA Puget Sound Health Care System for mental health diagnosis between the ages of 18-75 who meet all of the inclusion criteria with no indicators to any of the exclusionary criteria.

You may qualify if:

• Currently receiving outpatient care for mental health diagnosis at VA Puget Sound Health Care System (VA PSHCS) and referred by sub-investigator on listed for study
• Currently experiencing a sub-optimal medication response as assessed by either continue symptoms or medication side effects; which in the opinion of their treating provider would indicate or warrant a change in medications
• Currently prescribed at least five medications; two being for a mental health diagnosis OR one mental health medication prescribed for mental health diagnosis and one for mediating side effects related to the medication prescribed for the mental health diagnosis.
• Between the ages of 18-75.

You may not qualify if:

• Any mental health or physical health diagnosis, which in the opinion of their treating prescriber would prevent them from being compliant on a medication regimen or being able to complete the study measures.
• Current/active diagnosis of severe alcohol or drug use disorder
• Serious medical or mental health symptoms requiring immediate stabilization and/or hospitalization
• Impaired decision making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent
• Self-identification as being current pregnancy

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• Genomind, LLC: collaborator

Study Sites (1)

VA Puget Sound Health Care System

Tacoma, Washington, 98493, United States

Location

Related Publications (1)

• Wood AE, Agrawal D, Deem AP, Dupper Knoper TL, Merino RF, Molzof HE, Maus LE, Kim F, Lodin Z, Lim S. Medication Optimization Using Pharmacogenomic Testing in a Complex Mental Health Population Prescribed Psychiatric Polypharmacy. J Clin Pharmacol. 2022 Jul;62(7):898-904. doi: 10.1002/jcph.2032. Epub 2022 Mar 4.

  PMID: 35075665 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

a cheek swab tissue sample for DNA collection will be obtained from each consented study participant in order to complete the pharmacogenomic testing; via the Genecept Assay testing results.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Amanda E. Wood; Clinical Research Psychologist, VA PSHCS
• Organization: VA Puget Sound Health Care System

amanda.wood@va.gov

253-583-1652

Study Officials

• Amanda E Wood, PhD.

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: March 16, 2018
• Study Start: January 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 17, 2024
• Last Updated: April 23, 2024
• Results First Posted: February 28, 2022

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)