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Aripiprazole Decreases Symptoms of Mania in Paediatric Bipolar Disorder: Presented at AACAP
By Maria Bishop
BOSTON, MA -- November 1, 2007 -- Children and adolescents at the onset of bipolar disorder may achieve improvements in manic symptoms with aripiprazole, according to research presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP).
Lead author Kiki D. Chang, MD, Assistant Professor and Director, Pediatric Mood Disorders Clinic, Child and Adolescent Psychiatry, Stanford University School of Medicine, Stanford, California, United States, and colleagues undertook a 54-centre, 4-week study of 296 patients 10 to 17 years of age with bipolar disease.
Patients in the study were randomised to aripiprazole 10 mg (n = 98) or 30 mg (n = 99), or placebo (n = 99). The primary endpoint was mean baseline total score change in the Young Mania Rating Scale (YMRS).
Mean change from baseline to week 4 results in the 10-mg arm and the 30-mg arm demonstrated statistically significant improvements over results from the placebo arm, with approximately 17-point and 14-point reductions for treated patients versus an approximate 7 point-reduction for placebo subjects.
This trial was preceded by a washout period, although benzodiazepines and anticholinergics were allowed during the trial, if necessary.
Recent reports have claimed that the average age of onset for bipolar disorder is less than 13 years, Dr. Chang noted. The mean age of subjects in this trial was 13.43 years, with the vast majority being older than 12 years.
There is a paucity of trial data in this patient population, which is traditionally treated for bipolar disorder 1 with lithium, anticonvulsants and atypical antipsychotics, Dr. Chang said.
Aripiprazole is currently indicated for the treatment of acute manic and mixed episodes associated with bipolar 1 disorder in adults, and for maintaining efficacy in stable patients with bipolar disorder who have had a recent manic or mixed episode.
Funding for this study was provided by Otsuka Pharmaceutical Co., Ltd.
[Presentation title: Efficacy of Aripiprazole in Children (10-17) Years Old With Mania: Abstract B6]
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