Study Evaluating Bifeprunox in Bipolar Depression

Wyeth

Status and phase: Completed; Phase 3

Conditions: Depression Bipolar

Treatments: Drug: Bifeprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245973

3168A2-307

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women 18 to 65 years of age, inclusive.
• Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.

Exclusion criteria

• This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind