Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT00181870|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Mania||Drug: carbamazepine ER (Equetro)||Phase 4|
Initial clinical evidence suggests that carbamazepine (CBZ) may play a therapeutic role in the management of pediatric bipolar disorder. A recent study found that nearly 50% of patients taking immediate-release CBZ had side effects while only 20% of patients had side-effects after switching to an extended release (ER) version of the drug, despite high doses. In addition, with an ER formulation of CBZ there is a potential for decrease in peak-related side effects and improved efficacy with higher blood levels. Thus, an ER formulation of CBZ may improve effectiveness and adherence to treatment.
The goal of this pilot study is to evaluate the safety and effectiveness of Equetro in the treatment of bipolar I, bipolar II, and bipolar spectrum disorder in children ages 6-12 over the course of 8-weeks. We propose that during this exploratory study there will be sufficient safety, tolerability, and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder. The results of this study will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Study of Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||August 2007|
- symptom reduction measured by YMRS [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181870
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|