The Young Adult and Pediatric Bipolar Study

Study Overview
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Brief Summary
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To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.

Official Title
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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.

Conditions
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Bipolar I Disorder

Intervention / Treatment
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* Drug: Extended-Release Carbamazepine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnant or lactating females. Body weight less than or equal to 25 kg.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Equetro active<br> | Drug: Extended-Release Carbamazepine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months |