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Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder: a randomized, double-blind, placebo-controlled study

Authors


  • This research and writing and editorial assistance were supported by Johnson & Johnson Pharmaceutical Research and Development, LLC. MH, GP, SK, IVH, IA, and JQ are full-time employees of Johnson & Johnson Pharmaceutical Research and Development, LLC, and are J&J stockholders. MPD has received research support from AstraZeneca, Eli Lilly & Co., J&J, Shire, Janssen, Pfizer, Bristol-Myers Squibb, Repligen, Martek, Somerset, NIDA, NIMH, NIAAA, National Alliance for Research on Schizophrenia and Depression, the Thrasher Foundation, and GlaxoSmithKline; has participated on lecture bureaus for Bristol-Myers Squibb, AstraZeneca, and the France Foundation; and has served as a consultant on advisory boards and received honoraria from AstraZeneca, GlaxoSmithKline, Eli Lilly & Co., the France Foundation, Kappa Clinical, NIDA, Pfizer, and Medical Communications Media. VK was a full-time employee of Johnson & Johnson Pharmaceutical Research & Development, LLC, and a J&J stockholder at the time of this research.

Corresponding author:
Magali Haas, M.D., Ph.D.
CNS Translational Sciences
Johnson & Johnson Pharmaceutical Research and Development
Building 20, Room 1L7
Turnhoutseweg 30
2340 Beerse, Belgium
Fax: 32 14 60 6121
E-mail: mhaas8@its.jnj.com

Abstract

Objectives:  To evaluate the efficacy, safety, and tolerability of risperidone monotherapy for the treatment of an acute mixed or manic episode in children and adolescents with bipolar I disorder.

Methods:  This randomized, placebo-controlled, double-blind, 3-arm study (N = 169) included children and adolescents (ages 10–17 years) with a DSM-IV diagnosis of bipolar I disorder, experiencing a manic or mixed episode. Study participants were randomized to placebo (n = 58), risperidone 0.5–2.5 mg/day (n = 50), or risperidone 3–6 mg/day (n = 61) for 3 weeks. The primary efficacy measure was change in Young Mania Rating Scale (YMRS) total score from baseline to end point. Safety assessments included adverse event (AE) monitoring and scores on extrapyramidal symptom rating scales.

Results:  Improvement in mean YMRS total score was significantly greater in risperidone-treated subjects than in placebo-treated subjects [mean change (SD) −9.1 (11.0) for placebo; −18.5 (9.7) for risperidone 0.5–2.5 mg (p < 0.001); −16.5 (10.3) for risperidone 3–6 mg (p < 0.001)]. The most common risperidone-associated AEs were somnolence, headache, and fatigue. Mean (SD) weight gain was 0.7 (1.9) kg, 1.9 (1.7) kg, and 1.4 (2.4) kg in the placebo, risperidone 0.5–2.5 mg, and risperidone 3–6 mg groups, respectively, during this 3-week study.

Conclusions:  At daily doses of 0.5–2.5 mg and 3–6 mg, risperidone was effective and well tolerated in children and adolescents experiencing acute manic or mixed episodes of bipolar I disorder. Results indicate that risperidone 0.5–2.5 mg has a better benefit–risk profile than risperidone 3–6 mg.

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