Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

Lilly

Status and phase: Completed; Phase 4

Conditions: Depression, Bipolar

Treatments: Drug: Olanzapine; Drug: Fluoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191399

F1D-SU-HGMA

9370

Details and patient eligibility

About

The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders [Text Revision] (DSM-IV-TR) disease diagnostic criteria.
• Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR.
• Subjects must have an initial score at Visit 1 of at least 20 on the MADRS.

Exclusion criteria

• Any patient currently meeting DSM-IV-TR criteria rapid-cycling course.
• A CGI-Severity - Mania score of at least 3.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)