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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03468309
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Results First Posted : February 28, 2022
Last Update Posted : February 28, 2022
Sponsor:
Collaborator:
Genomind, LLC
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Study Description
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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.

Condition or disease Intervention/treatment
Pharmacogenetic Testing Genetic: Genecept Assay and G-DIG decision tool

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 Design
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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Medication Optimization Using Pharmacogenetic Testing and the Genomind Drug Interaction Guide (G-DIG) to Reduce Polypharmacy in a Mental Health Population
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Global Impression [ Time Frame: Baseline and 12-weeks ]
    Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.


Secondary Outcome Measures :
  1. Number of Psychiatric Medications [ Time Frame: Change from baseline to 12-weeks ]
    Number of psychiatric medications prescribed to the patient.

  2. 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.

  3. 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.


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.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468309


Locations
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United States, Washington
VA Puget Sound Health Care System
Tacoma, Washington, United States, 98493
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
Genomind, LLC
Investigators
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Principal Investigator: Amanda E Wood, PhD. VA Puget Sound Health Care System
Study Director: David S Krause, MD Genomind, LLC
  Study Documents (Full-Text)

Documents provided by Seattle Institute for Biomedical and Clinical Research:
Study Protocol and Statistical Analysis Plan  [PDF] March 21, 2018

More Information
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Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT03468309    
Other Study ID Numbers: 01600
First Posted: March 16, 2018    Key Record Dates
Results First Posted: February 28, 2022
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
polypharmacy
drug interactions
DNA testing
mental health diagnosis
 drug side effects
presciption treatment plans
mental health medication treatment plans