CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 211 enrolled
Drug / intervention
escitalopram +1 moredrug
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/NCT01655706
NCT01655706Phase 3Completed
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Integrated Biological Markers for the Prediction of Treatment Response in Depression

University Health Network, Toronto·interventional·Posted Aug 2, 2012·Updated May 11, 2018

In Brief

A Phase 3 clinical trial evaluating escitalopram and aripiprazole for Major Depressive Disorder. Completed, enrolled 211 participants across 6 sites.

Detailed Summary

This study is a pilot to assess feasibility of the protocol in patients and controls across six participating sites. The goal is to identify biological markers (biomarkers)that can be measured at baseline or early in treatment to predict treatment outcome in individual patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using interview and self-report measures), molecular (from blood samples) and neurobiological (using neuroimaging and EEG).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesCanada
CollaboratorsUniversity of Toronto, University of Calgary, University of British Columbia, McGill University, Queen's University, Centre for Addiction and Mental Health, McMaster University

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2, 2012
Enrollment StartApr 23, 2012
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.9 years ago

Interventions

escitalopramdrug

Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.

aripiprazoledrug

At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.