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

Area of Science:

• Psychiatry
• Pharmacology
• Clinical Trials

Background:

• Severe mania poses life-threatening risks, including suicide, and significantly impacts patients and families.
• There is a critical need for efficient and rapid control of acute manic episodes.

Purpose of the Study:

• To assess the safety and efficacy of risperidone as a monotherapy for acute mania.

Main Methods:

• A 3-week, randomized, double-blind trial involving 290 inpatients with bipolar I disorder.
• Participants had current manic or mixed episodes and a baseline Young Mania Rating Scale (YMRS) score ≥ 20.
• Flexible doses of risperidone (1-6 mg/day) or placebo were administered.

Main Results:

• Risperidone (n=146) showed significantly greater YMRS score improvements than placebo (n=144) at weeks 1, 2, and end-point (P < 0.01).
• Mean baseline YMRS score was 37.2.
• Extrapyramidal symptoms were the most common adverse events reported with risperidone.

Conclusions:

• Risperidone monotherapy demonstrated significant improvements in YMRS scores for severe manic symptoms, starting as early as week 1.
• Substantial efficacy was observed by the end of the study.
• The treatment was generally well-tolerated by patients.