Risperidone in the treatment of acute mania - Double-blind, placebo-controlled study
ABSTRACT 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.
To evaluate the safety and efficacy of risperidone monotherapy for acute mania.
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.
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.
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.
Article: Editor's replyThe British Journal of Psychiatry 05/2006; 188(5):491-492. DOI:10.1192/bjp.188.5.491 · 7.34 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: Objective To review scores on measures of impulsivity in remitted bipolar disorder. Data source We used keywords “impulsivity and bipolar”; “impulsivity and mania” to narrow down our search on Medline, EMBASE and Psychinfo to include those studies that had reported impulsivity scores using validated and reliable assessment measures in remitted bipolar disorder (Both I & II). We searched all English language studies from 1990 to October 2012. Study Selection 19 reports met the inclusion criteria and were reviewed by two abstractors independently. Data abstraction We generated weighted mean differences (WMDs) from pooled data using RevManager 5.0 from Cochrane analysis. Results The Barratt Impulsivity Scale (BIS) 11 was the instrument most commonly used. 19 studies met inclusion criteria, of which 2 were excluded due to incomplete data. A WMD of 12.8 was observed for BIS 11 total scores, 4.3 on the motor component, 4.1 on the cognitive and 7.6 on the non-planning components of the BIS 11 respectively. Conclusion Impulsivity is significantly higher in remitted bipolar patients than normal controls. Non-planning impulsivity is a key domain affected in bipolar disorder, which may represent a stable trait.Comprehensive Psychiatry 10/2014; 55(7). DOI:10.1016/j.comppsych.2014.05.010 · 2.26 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: Second-generation antipsychotics, approved for the treatment of mania, are associated with adverse effects such as weight gain and metabolic disorders. Aripiprazole, a recently introduced second-generation antipsychotic, are thought to account for its low propensity for weight gain, metabolic disturbances and sedation. The purpose of this study was to investigate the effect of risperidone versus aripiprazole in the treatment of acute mania. Fifty patients with acute episodes of mania were enrolled in this study, and they were randomly assigned into a risperidone group of 24 cases and an aripiprazole group of 26 cases. In group A, aripiprazole with a dose of 5-30 mg/day and in group B, risperidone with a dose of 2-8 mg/day was given to patients. The average dose of aripiprazole was 27 mg/day, and the average dose of risperidone was 6 mg/day. The effects of each drug for the treatment of acute mania were assessed on the 1(st) day of admission and on days 2, 4, 6, 8 and at weeks 2, 4 and 6 after therapy using the young mania rating scale (YMRS) and at the baseline and on weeks 3 and 6 after admission using the clinical global impression (CGI) scale. The mean age of the group of risperidone was 34 ± 8.6 years and in a group of aripiprazole it was 34 ± 9.1 years (P = 0.83). Comparison of YMRS scores over the period of 6 weeks revealed a statistically significant difference in both groups (P < 0.0001). There was also a statistically significant difference in YMRS scores between risperidone and aripiprazole at day 8 (P = 0.026) and weeks 2 (P = 0.035) and 4 (P = 0.042). There was also a statistically significant difference in CGI-Severity scale score at weeks 3 (P = 0.003) and 6 (P = 0.000) and in CGI-Improvement scale score at weeks 3 (P = 0.005) and 6 (P = 0.002). The most common side-effect observed in both groups was headache (0%15/4 in aripiprazole vs. %16/7 in risperidone). Aripiprazole that is readily available in our market, could be considered more effective than risperidone in the treatment of acute mania.Journal of research in medical sciences 08/2014; 19(8):733-738. · 0.61 Impact Factor