CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Antidepressant + Placebo +1 moredrug
Likely dose
Antidepressant + Placebo 20 mgfrom 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/NCT00095823
NCT00095823Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.

Bristol-Myers Squibb·interventional·Posted Nov 9, 2004·Updated Nov 25, 2013

In Brief

A Phase 3 clinical trial evaluating Antidepressant + Placebo and Antidepressant + Aripiprazole for Major Depressive Disorder. Completed, across 20 sites.

Detailed Summary

This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsOtsuka America Pharmaceutical

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartJun 1, 2004
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 21.6 years ago

Interventions

Antidepressant + Placebodrug

Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.

Antidepressant + Aripiprazoledrug

Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.