Study Evaluating Bifeprunox in Bipolar Depression

Wyeth

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Bifeprunox; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134459

B3101016 (Other Identifier)

3168A2-304

Details and patient eligibility

About

The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.

Enrollment: 434 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of bipolar disorder
• Experiencing a depressive episode

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind