Bipolar I Disorder
Conditions
Brief summary
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.
Interventions
Sponsors
Validus Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Key Inclusion Criteria: 1. DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed. 2. A lifetime history of bipolar disorder symptoms for at least 2 months. 3. YMRS score greater than or equal to 16. 4. CGI-S score greater than or equal to 4. 5. Male or female outpatient aged between 10-17 years old inclusive at the time of consent. 6. Functioning at an age-appropriate level intellectually, as deemed by the Investigator. 7. 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. 8. Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.
Exclusion criteria
* Key
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed