CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,398 enrolled
Drug / intervention
GeneSight Psychotropicgenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02109939
NCT02109939N/ACompleted
CompareCT.gov

12 Week, Randomized, Double-Blind, Controlled Evaluation Followed by an Open Label 12-Week Follow-up Period of the Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From A Major Depressive Disorder (MDD) Having Had- Within the Current Episode- An Inadequate Response to at Least One Medication Included in GeneSight Psychotropic

Assurex Health Inc.·interventional·Posted Apr 10, 2014·Updated Jan 14, 2020

In Brief

A clinical study evaluating GeneSight Psychotropic for Major Depressive Disorder (MDD). Completed, enrolled 1,398 participants across 61 sites.

Detailed Summary

Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder (MDD)
CountriesUnited States
CollaboratorsUniversity of Michigan

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 10, 2014
Enrollment StartApr 1, 2014
Primary CompletionApr 20, 2017
Study CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.2 years ago

Interventions

GeneSight Psychotropicgenetic

The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications. The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes. tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.