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

NCT00181870 Phase 4 COMPLETED

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.

Details

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	33
Start date	2005-07

Conditions

• Bipolar Disorder
• Mania

Interventions

• carbamazepine ER (Equetro)

Primary outcomes

• symptom reduction measured by YMRS — 8 weeks

Countries

United States