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Br J Psychiatry. 2005 Sep;187:229-34.

Risperidone in the treatment of acute mania: double-blind, placebo-controlled study.

Author information

  • 1The Psychiatric Clinic, Vasant Vihar, New Delhi, India. sumantk_2002@yahoo.co.in

Abstract

BACKGROUND:

Severe mania is life-threatening, carries an increased risk of suicide and has a serious impact on patients and their families. Efficient and rapid control of episodes of acute mania is needed.

AIMS:

To evaluate the safety and efficacy of risperidone monotherapy for acute mania.

METHOD:

In a 3-week, randomised, double-blind trial, 290 in-patients with bipolar I disorder with current manic or mixed episode and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexible doses of risperidone (1-6 mg per day) or placebo.

RESULTS:

Risperidone was received by 146 patients and placebo by144. Their mean baseline YMRS score was 37.2 (s.e.=0.5). Significantly greater improvements were observed with risperidone than with placebo at weeks 1 and 2 and at end-point (total YMRS: P <0.01). Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group.

CONCLUSIONS:

In patients with severe manic symptoms, risperidone produced significant improvements in YMRS scores as early as week 1 and substantial changes at end-point. Treatment was well tolerated.

Comment in

  • Trial of risperidone in India--concerns. [Br J Psychiatry. 2006]
PMID:
16135859
[PubMed - indexed for MEDLINE]
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