Elsevier

Biological Psychiatry

Volume 58, Issue 7, 1 October 2005, Pages 589-594
Biological Psychiatry

Advances in the neurobiology of pediatric bipolar disorder
Open-Label, 8-Week Trial of Olanzapine and Risperidone for the Treatment of Bipolar Disorder in Preschool-Age Children

https://doi.org/10.1016/j.biopsych.2005.03.019Get rights and content

Background

To evaluate short-term safety and efficacy of atypical antipsychotics in a single-site, prospective, open-label, 8-week study of risperidone and olanzapine monotherapy in preschoolers with bipolar disorder (BPD).

Methods

Risperidone was initiated at an open-label dose of .25 mg/day, increased weekly according to response and tolerability to a maximum does of 2.0 mg/day. Olanzapine was initiated at 1.25 mg/day and increased to no more than 10 mg/day.

Results

Thirty-one children aged 4–6 years were treated with olanzapine (n = 15, 6.3 ± 2.3 mg/day) or risperidone (n = 16, 1.4 ± .5 mg/day). At study end point (week 8 or last observation carried forward), there was a 18.3 ± 11.9 point (t = –5.6, p < .001) reduction in risperidone-treated subjects and a 12.1 ± 10.4 point (t = –4.4, p < .001) reduction in Young Mania Rating Scale (YMRS) scores in olanzapine-treated subjects that did not differ between groups (t = 1.4, p = .2). Response criteria (Clinical Global Impression improvement of “Much” or “Very Much” improved or a YMRS change of ≥ 30% or more) indicated no difference in rate of response with risperidone and olanzapine (69% vs. 53%, χ2(1) = .8, p = .4).

Conclusions

This prospective open study suggests that treatment with risperidone or olanzapine may result in a rapid reduction of symptoms of mania in preschool children with BPD. Because of substantial residual symptomatology and adverse effects, however, a pressing need exists to identify additional safe and effective treatments for the management of BPD in this high-risk population.

Section snippets

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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Copyright © 2005 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.