Clinical trial NCT03468309: Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population
Official title: Medication Optimization Using Pharmacogenetic Testing and the Genomind Drug Interaction Guide (G-DIG) to Reduce Polypharmacy in a Mental Health Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacogenetic Testing
Keywords: polypharmacy
drug interactions
DNA testing
mental health diagnosis
drug side effects
presciption treatment plans
mental health medication treatment plans
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: Genomind, LLC
First posted: 2018-03-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Clinical Global Impression
timeFrame: Baseline and 12-weeks
Secondary outcomes:
measure: Number of Psychiatric Medications
timeFrame: Change from baseline to 12-weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline to 12-weeks
measure: Generalized Anxiety Scale-7 (GAD-7)
timeFrame: Change from baseline to 12-weeks
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Amanda E Wood, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.