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.

Validus Pharmaceuticals26 sites in 1 country161 target enrollmentJuly 2006

ConditionsBipolar I Disorder

InterventionsExtended-Release Carbamazepine

DrugsExtended-Release Carbamazepine

Overview

Phase: Phase 4
Intervention: Extended-Release Carbamazepine
Conditions: Bipolar I Disorder
Sponsor: Validus Pharmaceuticals
Enrollment: 161
Locations: 26
Primary Endpoint: 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.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

October 2007

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Validus Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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
•CGI-S score greater than or equal to
•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.

Arms & Interventions

Equetro active

Intervention: Extended-Release Carbamazepine

Outcomes

Primary Outcomes

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 Outcomes

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)