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An open-label trial of divalproex sodium extended release for pediatric bipolar spectrum disorder in children age 6 - 12 years

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Open Journal of Psychiatry 2012年第2期2卷 123-128页

作者： Janet Wozniak paul hammerness Robert Doyle Gagan Joshi K. Yvonne Woodworth Joseph Biederman Pediatric Psychopharmacology Research Unit Massachusetts General Hospital Boston USA

Objective: To estimate the rate of response to divalproex sodium extended release in pediatric bipolar spectrum disorder in young children age 6 - 12. Methods: This was an 8-week, open-label treatment of youth with DSM-IV bipolar disorder with divalproex sodium extended release (ER) monotherapy. Severity of mania was assessed weekly with the Young Mania Rating Scale (YMRS). Results: The sample was 8.9 ± 2.0 years of age and predominantly male (83%). At study entry the mean YMRS score was 26.3 ± 4.5. Of the 18 subjects enrolled, 7 (39%) completed the 8 week course. We failed to find a clinically or statistically significant improvement with divalproex sodium ER. Pre-post comparisons at endpoint (LOCF) indicated an average response reduction of 6.1 ± 2.6 in the YMRS to a mean of 20.3 ± 8.1. Weight increased by 1.36 ± 0.7 kg (p = 0.08) from baseline to endpoint. Conclusion. Divalproex sodium ER monotherapy was associated with poor tolerability, was associated with clinically concerning weight gain but had modest therapeutic benefits in the management of symptoms of mania and depression in children with pediatric bipolar disorder.

关键词： Bipolar Disorders Pediatric Psychopharmacology Open-Label

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Impact of Long-Term Treatment with OROS Methylphenidate on Pubertal Development in Adolescents with ADHD

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Open Journal of Psychiatry 2014年第2期4卷 147-152页

作者： paul hammerness Daniel Geller Gagan Joshi Anna Georgiopoulos Robert Doyle Thomas Spencer Carter Petty Laura Mahoney Joseph Biederman Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD Massachusetts General Hospital Boston USA

The objective of this study was to examine whether stimulants impact pubertal development in adolescent Attention Deficit Hyperactivity Disorder (ADHD), an understudied subject. Pubertal staging data were collected during a 2-year open study of extended release methylphenidate in adolescents (N = 111) with ADHD. Tanner stages were compared to national estimates. The sample was primarily male, Caucasian, and a mean age of 14.8 years at baseline. The baseline Tanner stage for 70% of subjects was consistent with chronological age. For the majority of subjects who reached 12 - 20 months (N = 25) or 24 months (N = 21) endpoints, the Tanner stage at respective endpoints was consistent with age. We found that progression in Tanner stage was not associated with OROS MPH duration or dose (p > 0.10). Long-term treatment with extended release methylphenidate did not appear to adversely impact pubertal development in this sample of adolescents with ADHD.

关键词： Methylphenidate Puberty Development Adolescents ADHD

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