OBJECTIVE: This prospective 6-month open trial examined the effectiveness and safety of divalproex sodium (DVPX) in pediatric mixed mania. METHOD: Thirty-four subjects with a mean age of 12.3 (SD = 3.7) years, DSM-IV diagnosis of a current mixed episode and a baseline Young Mania Rating Scale (YMRS) score >20 were treated withDVPX monotherapy. The primary outcome measures were the YMRS and the Child Depression Rating Scale-Revised. Secondary measures were the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) and the Children's Global Assessment of Functioning Scale (C-GAS). Measures of safety and tolerability were also administered. RESULTS: Effect size (Cohen's d) based on change scores from baseline was 2.9 for the YMRS and 1.23 for the CDRS-R. Response rate (> or =50% change from baseline YMRS score and < or =40 score on CDRS-R at the end of study) was 73.5%. The remission rate (> or =50% change from baseline on YMRS, < or =40 on CDRS-R, CGI-BP-Improvement subscale of < or =2, and > or =51 CGAS score) was 52.9%. Significant improvements (p < 0.001) from baseline were seen for mean scores on all outcome measures (i.e., YMRS, CGI-BP, CDRS-R, and C-GAS). DVPX was safe and well tolerated with no serious adverse events during the 6-month trial. CONCLUSION: This study provides evidence for the effectiveness and safety of DVPX in the treatment of pediatric mixed mania over a 6-month period. Placebo-controlled, randomized trials involving larger samples will ultimately shed light on the efficacy of this agent.
RCT Entities:
OBJECTIVE: This prospective 6-month open trial examined the effectiveness and safety of divalproex sodium (DVPX) in pediatric mixed mania. METHOD: Thirty-four subjects with a mean age of 12.3 (SD = 3.7) years, DSM-IV diagnosis of a current mixed episode and a baseline Young Mania Rating Scale (YMRS) score >20 were treated with DVPX monotherapy. The primary outcome measures were the YMRS and the ChildDepression Rating Scale-Revised. Secondary measures were the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) and the Children's Global Assessment of Functioning Scale (C-GAS). Measures of safety and tolerability were also administered. RESULTS: Effect size (Cohen's d) based on change scores from baseline was 2.9 for the YMRS and 1.23 for the CDRS-R. Response rate (> or =50% change from baseline YMRS score and < or =40 score on CDRS-R at the end of study) was 73.5%. The remission rate (> or =50% change from baseline on YMRS, < or =40 on CDRS-R, CGI-BP-Improvement subscale of < or =2, and > or =51 CGAS score) was 52.9%. Significant improvements (p < 0.001) from baseline were seen for mean scores on all outcome measures (i.e., YMRS, CGI-BP, CDRS-R, and C-GAS). DVPX was safe and well tolerated with no serious adverse events during the 6-month trial. CONCLUSION: This study provides evidence for the effectiveness and safety of DVPX in the treatment of pediatric mixed mania over a 6-month period. Placebo-controlled, randomized trials involving larger samples will ultimately shed light on the efficacy of this agent.
Authors: Mani N Pavuluri; Alessandra M Passarotti; Jacklynn M Fitzgerald; Ezra Wegbreit; John A Sweeney Journal: J Am Acad Child Adolesc Psychiatry Date: 2011-12-23 Impact factor: 8.829
Authors: Ezra Wegbreit; James A Ellis; Aneesh Nandam; Jacklynn M Fitzgerald; Alessandra M Passarotti; Mani N Pavuluri; Michael C Stevens Journal: Brain Connect Date: 2011-12-07
Authors: Mani N Pavuluri; David B Henry; Robert L Findling; Stephanie Parnes; Julie A Carbray; Tahseen Mohammed; Philip G Janicak; John A Sweeney Journal: Bipolar Disord Date: 2010-09 Impact factor: 6.744
Authors: Lakshmi N Yatham; Sidney H Kennedy; Sagar V Parikh; Ayal Schaffer; David J Bond; Benicio N Frey; Verinder Sharma; Benjamin I Goldstein; Soham Rej; Serge Beaulieu; Martin Alda; Glenda MacQueen; Roumen V Milev; Arun Ravindran; Claire O'Donovan; Diane McIntosh; Raymond W Lam; Gustavo Vazquez; Flavio Kapczinski; Roger S McIntyre; Jan Kozicky; Shigenobu Kanba; Beny Lafer; Trisha Suppes; Joseph R Calabrese; Eduard Vieta; Gin Malhi; Robert M Post; Michael Berk Journal: Bipolar Disord Date: 2018-03-14 Impact factor: 6.744