CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Genecept Assay and G-DIG decision toolgenetic
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03468309
NCT03468309N/ACompleted

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

Seattle Institute for Biomedical and Clinical Research·observational·Posted Mar 16, 2018·Updated Apr 23, 2024

In Brief

An observational study evaluating Genecept Assay and G-DIG decision tool for Pharmacogenetic Testing. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenomind, LLC

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 16, 2018
Enrollment StartJan 1, 2018
Primary CompletionApr 1, 2019
Study CompletionApr 17, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.3 years ago

Interventions

Genecept Assay and G-DIG decision toolgenetic

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.