Acute manic and mixed episodes associated with Bipolar I Disorder
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial. -Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed" -Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria Subjects who show exacerbation of condition or no change in condition: Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition) Subjects who discontinued due to lack of drug efficacy: Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Efficacy | — |
Outcome results
None listed