Advances in the neurobiology of pediatric bipolar disorderOpen-Label, 8-Week Trial of Olanzapine and Risperidone for the Treatment of Bipolar Disorder in Preschool-Age Children
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Methods and Materials
The study consisted of an 8-week, open-label treatment with risperidone or olanzapine. All study procedures were reviewed and approved by the Partners Human Research Committee, Institutional Review Board, at Massachusetts General Hospital. All subjects’ parents or guardians signed written informed consent forms.
Male or female subjects, aged 4–6 years, were included in the trial. Each subject met criteria for DSM-IV bipolar I disorder, DSM-IV bipolar II disorder, or bipolar disorder not
Results
Thirty-one subjects were enrolled in the trial (n = 16 for risperidone and n = 15 for olanzapine). Seventy-seven percent (n = 24) of subjects completed the 8-week phase of the study. The rate of dropout was statistically significantly greater for olanzapine than for risperidone (n = 6 [40%] vs. n = 1 (6%), respectively; χ2(1) = 5.0, p = .03). Reasons for dropout included side effects (n = 1), lack of efficacy (n = 4), and loss to follow-up (n = 2).
As shown in Table 1, there were no differences
Discussion
This was a prospective, open-label treatment trial of risperidone or olanzapine for the treatment of acute mania in preschool-age children with bipolar I and bipolar disorder NOS. Intent-to-treat analysis showed that subjects demonstrated statistically significant improvement in manic symptoms with both risperidone and olanzapine. In addition, treatment with risperidone was also associated with a statistically significant improvement in symptoms of depression. A greater increase in prolactin
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