Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population (MedOPT)
|ClinicalTrials.gov Identifier: NCT03468309|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment|
|Pharmacogenetic Testing||Genetic: Genecept Assay and G-DIG decision tool|
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 :||Observational|
|Actual Enrollment :||53 participants|
|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|
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.
- Clinical Global Impression [ Time Frame: Change from baseline to 12-weeks ]Clinical Global Impression score for overall symptomology of the patient. Range of the CGI is 1-6, with 1 being less symptomology and 6 being high symptomology.
- Number of psychiatric medications [ Time Frame: Change from baseline to 12-weeks ]Number of psychiatric medications prescribed to the patient.
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Change from baseline to 12-weeks ]The PHQ-9 is a scale of depression. Scores range from 0-27, with 0 representing less depression.
- Generalized Anxiety Scale-7 (GAD-7) [ Time Frame: Change from baseline to 12-weeks ]The GAD-7 is a measure of anxiety, with scores ranging from 0-21, with 0 representing less anxiety.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468309
|United States, Washington|
|VA Puget Sound Health Care System|
|Tacoma, Washington, United States, 98493|
|Principal Investigator:||Amanda E Wood, PhD.||VA Puget Sound Health Care System|
|Study Director:||David S Krause, MD||Genomind, LLC|