CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 349 enrolled
Drug / intervention
Aripiprazole+ ADT +1 moredrug
Likely dose
Aripiprazole 2–20 mg orally once dailyAI-extracted
Key inclusion· 4
  • Age 18–65 years
  • Single or recurrent, non-psychotic episodes of major depressive disorder
  • Current episode of major depressive disorder lasting at least 8 weeks
  • Inadequate response to at least 1 and no more than 3 adequate antidepressant trials
Key exclusion· 0

None specified.

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

Search/NCT00105196
NCT00105196Phase 3Completed

A Study of Aripiprazole in Patients With Major Depressive Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Mar 10, 2005·Updated Dec 2, 2013

In Brief

A Phase 3 clinical trial evaluating Aripiprazole+ ADT and Placebo+ ADT for Major Depressive Disorder. Completed, enrolled 349 participants across 34 sites.

Detailed Summary

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2005
Enrollment StartMar 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 21.3 years ago

Interventions

Aripiprazole+ ADTdrug

Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Placebo+ ADTdrug

Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks