N/A
N=53
Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population
Pharmacogenetic Testing
Bottom Line
View on ClinicalTrials.gov: NCT03468309 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Clinical Global Impression — 4.07; 3.96 units on a scale — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Genecept Assay and G-DIG decision tool (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression |
4.07; 3.96 | <0.05 sig |
| SECONDARY Number of Psychiatric Medications |
3.85; 3.70 | <0.05 sig |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
15.81; 13.43 | <0.05 sig |
| SECONDARY Generalized Anxiety Scale-7 (GAD-7) |
13.60; 12.02 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
- 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.
- Between the ages of 18-75.
Exclusion Criteria
- 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.
- Current/active diagnosis of severe alcohol or drug use disorder
- Serious medical or mental health symptoms requiring immediate stabilization and/or hospitalization
- Impaired decision making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent
- Self-identification as being current pregnancy
Data sourced from ClinicalTrials.gov (NCT03468309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.