Abstract
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 ≤ 3, was achieved in 76% of patients, 90% of whom were at least markedly ill (CGI-I ≥ 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.
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Notes
ap-value based on chi-square test.
ap-value based on 1-way between subjects ANOVA.
bResponse is defined as achieving a CGI-I ≤ 3.
cp-value based on chi-square test.
dDose at date of CGI-I in responders.
ap-value based on chi-square test.