drugset / Trial / NCT00181870

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

NCT00181870

Phase 4 Completed 33 enrolled Massachusetts General Hospital Shire · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-07
Primary completion
2007-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbamazepine Small molecule 1200 mg