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Completed

NCT Number: NCT00245973

Study Evaluating Bifeprunox in Bipolar Depression

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.

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Key information

Conditions

Depression Bipolar Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bifeprunox

Drug

Primary outcomes

  1. Secondary measurement scales will be used:

  2. Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8

Secondary outcomes

  1. Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8

  2. Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8

  3. Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8

  4. Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8

  5. Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • Solvay Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Oct 28, 2005
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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