Abstract | BACKGROUND: Despite the increasing recognition of bipolar disorder in childhood, there have been no controlled, randomized clinical trials of atypical antipsychotics in this population. Preliminary data from open-label trials in children suggest that these agents might be effective in treating pediatric bipolar disorder, however. OBJECTIVE: METHODS: This report presents a secondary analysis of a previously reported 6-week, multicenter, double-blind, randomized, parallel-arm trial comparing 6 weeks of administration of risperidone (flexible dosing starting at 0.02 mg . kg .1 . d(-1) and titrated up to 0.06 mg kg(-1) d(-1)) versus placebo in children with DBDs and subaverage intelligence. Twenty-four candidate affective symptoms of mania and depression were extracted from the 64-item Nisonger Child Behavior Rating Form (NCBRF). To define independent dimensions of mood-disorder psychopathology, these 24 symptoms were assigned 1 of 3 independent dimensions (symptoms of mania) based on loading: explosive irritability; agitated, expansive, grandiose; and depression. A fourth, nonaffective independent dimension encompassed a combination of nonaffec tive symptoms on the NCBRF Conduct Problem subscale. To assess treatment effect, each independent dimension was assigned a score derived from the sum of the symptoms that loaded on that dimension at weeks 2, 4, and 6 of study drug administration. RESULTS: A total of 110 patients were included in the independent-dimension analysis (89 boys, 21 girls; risperidone, 49 patients; placebo, 61 patients; mean [SD] age, 8.6 [2.3] and 8.1 [2.4] years in the risperidone and placebo groups, respectively; mean [SD] weight, 33.9 [12.8] and 32.1 [12.0] kg in the risperidone and placebo groups, respectively). The treatment-effect analysis found that the mean scores of all 3 independent dimensions were significantly reduced with risperidone compared with placebo at weeks 2, 4, and 6 (all, P <or= 0.03). The effect sizes of improvement in these factors ranXged from 0.44 to 0.95 at end point. CONCLUSIONS: The results of this post hoc analysis of affective symptoms of DBDs using data from a previously published randomized, double-blind clinical comparison of risperidone and placebo in the treatment of children with DBDs and subaverage intelligence suggest that risperidone was effective in treating the factors of explosive irritability; agitated, expansive, grandiose; and depression.
|
Authors | Joseph Biederman, Eric Mick, Stephen V Faraone, Janet Wozniak, Thomas Spencer, Gahan Pandina |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 28
Issue 5
Pg. 794-800
(May 2006)
ISSN: 0149-2918 [Print] United States |
PMID | 16861101
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antipsychotic Agents
- Risperidone
|
Topics |
- Affective Symptoms
(drug therapy)
- Antipsychotic Agents
(therapeutic use)
- Attention Deficit and Disruptive Behavior Disorders
(drug therapy)
- Depression
(drug therapy)
- Double-Blind Method
- Humans
- Intellectual Disability
- Irritable Mood
(drug effects)
- Psychomotor Agitation
(drug therapy)
- Risperidone
(therapeutic use)
|