Clinical trial NCT00245973: Study Evaluating Bifeprunox in Bipolar Depression
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression Bipolar
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2005-10-28
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Secondary measurement scales will be used:
measure: Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
Secondary outcomes:
measure: Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
measure: Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
measure: Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
measure: Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
measure: Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Beverly Hills
country: United States
state: California
city: National City
country: United States
state: California
city: Stanford
country: United States
state: California
city: Farmington Hills
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Smyrna
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Terre Haute
country: United States
state: Indiana
city: Florence
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Rockville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Farmington Hills
country: United States
state: Michigan
city: St Charles
country: United States
state: Missouri
city: Clementon
country: United States
state: New Jersey
city: Moorestown
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Lawrence
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Brown Deer
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References: