Risperidone in the treatment of acute mania - Double-blind, placebo-controlled study
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.
Available from: Ayşegül Yildiz
- "Placeboassociated improvement in mean mania ratings relative to baseline varied greatly, from À19% (Zarate et al, 2007) or + 0.63% (Pope et al, 1991) to + 38% (McIntyre et al, 2009a). Likewise, study drop-out rates ranged from 13–15% (Kushner et al, 2006; Smulevich et al, 2005, respectively) to 82% (Hirschfeld et al, 2010) with placebo, and from 11–14% (Bowden et al, 2005; Khanna et al, 2005; Smulevich et al, 2005) to 83% (Hirschfeld et al, 2010) with drug. The impact of these sources of variance lie beyond this study and are reported separately (Yildiz et al, 2010). "
Available from: Kesavan Muralidharan
- "In order to ascertain if SGA have similar efficacy in treating manic symptoms in mixed episodes as in pure mania, we computed SMD for SGA separately for these two conditions. For this analysis, we compared the effect sizes of seven of the nine included RCTs (Suppes et al., 2008; Khanna et al., 2005; McIntyre et al., 2009; Sachs et al., 2002; Tohen et al., 2002; Keck et al., 2003a, 2003b; Berwaerts et al., 2012) that reported data for pure manic and mixed episodes separately (Fig. 4 a and b). The SMD for SGA to placebo was comparable in both pure mania [−0.56, 95% CI −0.69, −0.42; total n¼ 1522] and mixed episodes [−0.44, 95% CI −0.59, −0.29; total n¼ 727]. "
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ABSTRACT: BACKGROUND: The literature on the treatment mixed episodes in Bipolar Disorder [BD] is sparse. Second generation antipsychotics [SGA] have documented efficacy in mania, but not mixed episodes. The objective of this meta-analysis was to ascertain the efficacy of SGA, either as mono- and/or adjunctive therapy, in the treatment of acute mixed episodes of BD, compared to placebo. METHODS: A MEDLINE search for English language publications of randomized controlled trials [RCTs] comparing SGA with placebo in the treatment of an acute manic/mixed episode of BD, during the period 1990-2012, was performed using the terms 'atypical antipsychotics', 'SGA', 'mixed episodes', 'dysphoric mania' and each SGA independently. 9 RCTs reporting data on 1289 mixed episode patients treated with aripiprazole, asenapine, olanzapine, paliperidone-ER, risperidone, and ziprasidone, either as monotherapy or as adjunctive therapy, versus placebo, for 3-6 weeks, were included in the meta-analysis. We extracted data on the number of patients, SGA, duration of study and mean change in mania and depression scores from baseline to endpoint. Standardized mean difference between SGA and placebo for the mean baseline-to-endpoint change in mania and depression rating scores was calculated, with a 95% confidence limit. RESULTS: SGA, either alone or in combination with mood stabilizers, had superior efficacy in treating manic symptoms of mixed episodes compared to placebo (-0.41, 95% CI -0.53, -0.30; overall effect p<0.00001). SGA were equally effective for manic symptoms in mixed episodes and pure mania (p=0.99). SGA had superior efficacy in treating depressive symptoms of mixed episodes (-0.30, 95% CI -0.47, -0.13; p<0.001) compared to placebo in two trials reporting this information. LIMITATIONS: Thirteen relevant studies could not be included as data for mixed-episodes were not presented separately. CONCLUSIONS: SGA are effective in treating acute mixed episodes of BD, with predominant manic symptoms. Their efficacy in treating depressed mixed episodes remains unclear.
Available from: Bettahalasoor Somashekar
- "Risperidone is well tolerated at low doses but at 6mgs/day, nearly 50% patients may develop extra pyramidal side-effects (Khanna et al. 2005). "
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