CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
Aripiprazole 5mg +2 moredrug
Likely dose
Aripiprazole 5mgfrom 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/NCT00683852
NCT00683852Phase 3Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy (ADT) Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior ADT

Massachusetts General Hospital·interventional·Posted May 26, 2008·Updated Jul 19, 2017

In Brief

A Phase 3 clinical trial evaluating Aripiprazole 5mg, Aripiprazole 2mg, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 225 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether a reduced dose of aripiprazole is effective in treating patients with major depressive disorder

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.1 years ago

Interventions

Aripiprazole 5mgdrug

Tablet dose of aripiprazole will be 2 mg/day during the first phase (30 days) of the study, and 5 mg/day in the second phase (30 days)

Aripiprazole 2mgdrug

For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study (30 days)

Placebodrug

for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study (60 days)