Depression Bipolar
Conditions
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.
Interventions
DRUGBifeprunox
Sponsors
Solvay Pharmaceuticals
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary measurement scales will be used: | — |
| Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 | — |
| Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 | — |
| Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8 | — |
| Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 | — |
| Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8 | — |
Countries
United States
Outcome results
None listed