NCT00181870

Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder

Open-Label Study of Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. The main goal of this study is to begin to address the void of information on safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder.

Detailed description

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.

Conditions

• Bipolar Disorder
• Mania

Interventions

Type	Name	Description
DRUG	carbamazepine ER (Equetro)

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-08-01
• First posted: 2005-09-16
• Last updated: 2010-06-22

Locations

1 site across 1 country: United States