A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder

Otsuka

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Antidepressant + Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095745

CN138-164

Details and patient eligibility

About

This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.

Enrollment: 1,002 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Men and women, 18 years or older
• Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
• Treatment history of an inadequate response to at least one and no more than four antidepressants

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,002 participants in 1 patient group

Antidepressant + Aripiprazole

No Intervention group

Treatment:

Drug: Antidepressant + Aripiprazole