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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-04-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects

NCT03748355

Psychiatric Disorder

COMPLETED NA

Preemptive Pharmacogenomics Testing Among Geriatric Patients

NCT05091879

Polypharmacy Pharmacogenomic Testing

ENROLLING_BY_INVITATION NA

An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay

NCT01507155

Treatment Resistant Depression Generalized Anxiety Disorder

COMPLETED NA

Pharmacogenomic Testing Of the Elderly To Reduce Morbidity

NCT02095769

Genetics of Drug Metabolism

UNKNOWN

Utility of PharmacoGenomics for Reducing Adverse Drug Effects

NCT02081872

Genetics of Drug Metabolism

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and increased the risk of drug-drug interactions and adverse side effects. Pharmacogenetic assays have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. One such assay is the Genecept® Assay produced by Genomind, which detects 63 allele polymorphisms of 18 genes. In addition, Genomind has developed the Genomind Drug Interaction Guide (G-DIG), which examines drug-drug-gene interactions. This computerized decision tool for medication providers uses the genetic information from the Genecept® Assay to look at the current medications being utilized to determine if there are specific drug-drug interactions that may be relevant given the individual's specific genetic test results.

This is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing information to both providers and patients. Fifty Veterans within the VAPSHCS who are prescribed polypharmacy, as defined as five or more medications, with at least two prescribed for a mental health diagnosis, and have a sub-optimal treatment effect will be enrolled in this study. Participating subjects will sign informed consent and a sample will be obtained in order to complete the pharmacogenomic testing. Medication providers who are participating in this study will utilize the pharmacogenetic assay results along with the G-DIG tool to design an optimized medication regime. The overall global level of symptoms and other patient symptoms measures will be administered at baseline, 6-weeks, and 12-weeks. The provider's medication plans will be compared before and after the pharmacogenetic assay information is provided. Number of medications will be reviewed to determine any reduction in polypharmacy and healthcare costs. The clinical global improvement scale (CGI) and patient assessments, including measures of depression, anxiety, PTSD, insomnia, pain, drug and alcohol use, quality of life, side effects, and medication adherence will be administered at baseline, 6-weeks, and 12-weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacogenetic Testing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Genecept Assay and G-DIG decision tool

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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
2. 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
3. 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.
4. Between the ages of 18-75.

Exclusion Criteria

1. 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.
2. Current/active diagnosis of severe alcohol or drug use disorder
3. Serious medical or mental health symptoms requiring immediate stabilization and/or hospitalization
4. Impaired decision making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent
5. Self-identification as being current pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No