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

April 17, 2024 updated by: Seattle Institute for Biomedical and Clinical Research

Medication Optimization Using Pharmacogenetic Testing and the Genomind Drug Interaction Guide (G-DIG) to Reduce Polypharmacy in a Mental Health Population

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98493
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Global Impression
Time Frame: Baseline and 12-weeks
Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.
Baseline and 12-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Psychiatric Medications
Time Frame: Change from baseline to 12-weeks
Number of psychiatric medications prescribed to the patient.
Change from baseline to 12-weeks
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Change from baseline to 12-weeks
Patient Health Questionnaire-9 is a scale of depression, scores range from 0-27, with 0 representing less depression and 27 representing more depression.
Change from baseline to 12-weeks
Generalized Anxiety Scale-7 (GAD-7)
Time Frame: Change from baseline to 12-weeks
Generalized Anxiety Scale-7 is a measure of anxiety, scores range from 0-21, with 0 representing less anxiety and 7 representing more anxiety.
Change from baseline to 12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Institute for Biomedical and Clinical Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genomind, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda E Wood, PhD., VA Puget Sound Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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