A Study of Aripiprazole in Patients With Major Depressive Disorder

Otsuka

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Aripiprazole+ ADT; Drug: Placebo+ ADT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00105196

CN138-165

Details and patient eligibility

About

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.

Enrollment: 349 patients

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 who have experienced single or recurrent, non-psychotic episodes of 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 adequate antidepressant trials.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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349 participants in 2 patient groups, including a placebo group

A1

Experimental group

Treatment:

Drug: Aripiprazole+ ADT

A2

Placebo Comparator group

Treatment:

Drug: Placebo+ ADT