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A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment. [ Time Frame: 6 months ]
Secondary Outcome Measures :
Reduction of bipolar symptoms as assessed by the Young Mania Rating Scale (YMRS), Clinical Global Impressions Scale (CGI) and Children's Depression Rating Scale (CDRS-S) after 6 months of treatment. [ Time Frame: 6 months ]
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Layout table for eligibility information
Ages Eligible for Study:
10 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.
A lifetime history of bipolar disorder symptoms for at least 2 months.
YMRS score greater than or equal to 16.
CGI-S score greater than or equal to 4.
Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.
Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.
Key Exclusion Criteria:
Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.
A history of lack of therapeutic response or hypersensitivity to the study drug.
A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
A history of aplastic anemia, agranulocytosis or bone marrow depression.
A history of seizure disorder, other than a single childhood febrile seizure.
A history of severe, unstable asthma.
Current hospitalization for psychiatric symptoms.
History of alcohol or other substance abuse or dependence.