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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
380
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
Clinical Global Impressions Severity of Illness Score (CGI-S),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
Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Positive and Negative Symptom Scale (PANSS) at 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
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Unnamed facility
Birmingham, Alabama, United States
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Beverly Hills, California, United States
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National City, California, United States
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Stanford, California, United States
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Farmington Hills, Connecticut, United States
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Bradenton, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
Unnamed facility
Smyrna, Georgia, United States
...and 30 more locations