Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive

Status Terminated

Clinical Trial Summary

This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder

Clinical Trial Description

Major Depressive Disorder is a chronic psychiatric illness that leads to devastating consequences at the individual and societal levels. Today, the choice of treatment continues to be largely based on subjective factors, primarily the clinician and/or patient's preferences, as well as the individual's history of response to treatment, often tainted by recall bias. Psychiatric medication decisions are even more arbitrary when the subject in question has not had past treatment trials. This often leads to a trial and error process and an increasingly resistant disease with each failed trial. Early implementation of an objective tool designed for tailoring medication choice to an individual may prove highly beneficial in decreasing illness chronicity, individual suffering, and economic burden.

GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we propose conducting a randomized, double blind, controlled trial to evaluate the impact of the GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve (never having taken medication for depression) Major Depressive Disorder.

This study will involve 6 visits over about 24 weeks where participants will be randomized to have their study clinician have access to their pharmacogenetic report in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03537547
Study type	Interventional
Source	Washington University School of Medicine
Contact
Status	Terminated
Phase	Phase 4
Start date	May 4, 2018
Completion date	August 19, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms