CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Escitalopram +3 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/NCT00953745
NCT00953745N/ACompleted
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Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression: A Raclopride/F-DOPA Positron Emission Tomography and Functional MRI Study

Washington University School of Medicine·interventional·Posted Aug 6, 2009·Updated Apr 19, 2018

In Brief

A clinical study evaluating Escitalopram, Aripiprazole, and 2 other interventions for Major Depressive Disorder. Completed, enrolled 43 participants across 1 site.

Detailed Summary

Aripiprazole has been approved by the FDA for augmenting ineffective/partially effective oral antidepressant therapy in patients suffering from major depression. The mechanism by which this augmentation is achieved is not known. This study has been designed to test the hypothesis that the primary mechanism of action of aripiprazole (ARP) antidepressant augmentation is through the dopaminergic pathway. Two positron emission tomography (PET) scan procedures and a functional magnetic resonance imaging (fMRI) scan will be used to test this hypothesis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartMay 1, 2009
Primary CompletionJun 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.9 years ago

Interventions

Escitalopramdrug

All subjects will begin on escitalopram and placebo for 8 weeks

Aripiprazoledrug

Subjects who fail to respond to Escitalopram will continue on Escitalopram and augment with active Aripiprazole.

Placebo Capsuledrug

All subjects will begin on escitalopram and placebo capsule for 8 weeks.

Placebo Tabletdrug

After 8 weeks, subjects will be given a 2 week supply of escitalopram and placebo tablet.