Carbamazepine extended-release capsules: a retrospective review of its use in children and adolescents.

Background: Bipolar disorder occurs in 1% of children and adolescents, but few clinical trials address treatment of this population. This retrospective chart review evaluated the long-term safety and tolerability of carbamazepine extended-release capsules (CBZ-ERC) (Shire, Wayne, PA, USA) in 300 children and adolescent patients who had been treated for bipolar disorder in a private psychiatric practice.

Methods: Data were collected from the medical records of all young and adolescent (4-17 years old) patients who met the DSM-IV criteria for a diagnosis of bipolar disorder type I, type II, or bipolar not otherwise specified who had been treated with CBZ-ERC either as add-on or monotherapy between October 1998 and November 2003 at Red Oak Psychiatry Associates, Houston, TX. The severity of illness was assessed using the Clinical Global Impression-Severity scale, and improvement was measured by the Clinical Global Impression-Improvement (CGI-I) scale.

Results: A response, defined as a CGI-I score of or=5) at CBZ-ERC initiation. Treatment was well tolerated, with the most common adverse events being somnolence (9.7%), nausea (6.3%), dizziness (5.0%), and rash (4.3%).

Conclusions: Carbamazepine extended-release capsules appear safe and efficacious for the treatment of bipolar disorders in children and adolescent patients.