NCT03468309: MedOPT

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

Completed Results posted Last updated 23 April 2024

What this trial tests

trial testing Genecept Assay and G-DIG decision tool in Pharmacogenetic Testing in 53 participants. Completed in 17 April 2024.

Timeline

1 January 2018

Primary endpoint
1 April 2019

17 April 2024

Quick facts

Lead sponsor	Seattle Institute for Biomedical and Clinical Research
Status	Completed
Study type	OBSERVATIONAL
Enrollment	53
Start date	1 January 2018
Primary completion	1 April 2019
Estimated completion	17 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Genecept Assay and G-DIG decision tool

Conditions studied

• Pharmacogenetic Testing — all drugs for Pharmacogenetic Testing →

Sponsor

Seattle Institute for Biomedical and Clinical Research

Who can join

Adults 18 to 75, any sex, with Pharmacogenetic Testing. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Global Impression Primary · Baseline and 12-weeks

Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.

CGI at baseline

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	4.07	± .62

CGI at 12-weeks

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	3.96	± .59

Number of Psychiatric Medications Secondary · Change from baseline to 12-weeks

Number of psychiatric medications prescribed to the patient.

Psychiatric meds at baseline

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	3.85	± 1.41

Psychiatric meds at 12-weeks

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	3.70	± 1.37

Patient Health Questionnaire-9 (PHQ-9) Secondary · 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.

PHQ-9 at baseline

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	15.81	± 5.68

PHQ-9 at 12-weeks

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	13.43	± 6.39

Generalized Anxiety Scale-7 (GAD-7) Secondary · 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.

GAD-7 at baseline

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	13.60	± 5.53

GAD-7 at 12-weeks

Group	Value	95% CI
Genecept Assay and G-DIG Decision Tool	12.02	± 5.90

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multi-gene Pharmacogenomic Testing That Includes Decision-Support Tools to Guide Medication Selection for Major Depression: A Health Technology Assessment.
   Ontario Health (Quality) . · · 2021 · cited 14× · PMID 34484487