Vol 10: The safety and effectiveness of open-label extended-release carbamazepine in the treatment of children and adolescents with bipolar I disorder suffering from a manic or mixed episode.Reportar como inadecuado



 Vol 10: The safety and effectiveness of open-label extended-release carbamazepine in the treatment of children and adolescents with bipolar I disorder suffering from a manic or mixed episode.


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This article is from Neuropsychiatric Disease and Treatment, volume 10.AbstractObjective: To assess the safety and effectiveness of open-label treatment with extended-release carbamazepine ERC in pediatric subjects suffering from bipolar I disorder. Method: Medically healthy youths aged 10–17 years suffering from an acute manic or mixed episode were eligible. After screening for study eligibility, the youths began a 5-week titration period in which doses of ERC were adjusted in order to optimize benefit whilst minimizing adverse events, at doses between 200–1,200 mg-day. Thereafter, subjects could continue to receive treatment during a subsequent 21-week period. Safety measures included spontaneously reported adverse events AEs and laboratory assessments. The primary efficacy measure was the Young Mania Rating Scale YMRS. Results: A total of 60 children ages 10–12 and 97 adolescents ages 13–17, with an overall average age of 13.4 years standard deviation SD 2.0 years received ERC. The mean duration of study participation was 109.6 days SD 70.2 days, with 66 42% completing the entire study. At end of study participation end point, the most prevalent dose of ERC was 1,200 mg: 31.7% of children and 24.7% of adolescents reached the 1,200 mg dose. The YMRS decreased from a mean of 28.6 SD 6.2 at baseline to a mean of 13.8 SD 9.4 P



Autor: Findling, Robert L; Ginsberg, Lawrence D

Fuente: https://archive.org/







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