A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Bristol-Myers Squibb1,200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,200

Conditions

Major Depressive Disorder

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women, 18-65 years old * Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration. * Treatment history of an inadequate response to at least one and no more than three antidepressants.

Locations (28)

Local Institution

Beverly Hills, California, United States

Outcomes

Primary Outcomes

Change in a depression rating scale at endpoint

Secondary Outcomes

Change in a disability scale and Clinical Global Impression scale at endpoint

Data from ClinicalTrials.gov

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