A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Antidepressant + Aripiprazole; Drug: Antidepressant + Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095758

CN138-163

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,200 participants in 2 patient groups, including a placebo group

A1

Placebo Comparator group

Treatment:

Drug: Antidepressant + Placebo

A2

Active Comparator group

Treatment:

Drug: Antidepressant + Aripiprazole