Study Evaluating Bifeprunox in Bipolar Depression

Depression Bipolar Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245973
• Other study ID #: 3168A2-307
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2005
• Last updated: December 3, 2007
• Start date: June 2005
• Est. completion date: October 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression Bipolar
• Depressive Disorder

Intervention

Drug:
• Bifeprunox

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary measurement scales will be used:
Primary	Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
Secondary	Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Secondary	Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
Secondary	Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Secondary	Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Secondary	Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8