MedTrace Logo

A Study of Aripiprazole in Patients With Major Depressive Disorder

NCT00105196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2013-12-02

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Aripiprazole+ ADT

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

DRUG

Placebo+ ADT

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

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00105196 on ClinicalTrials.gov