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Evidence summaries

Risperidone for Psychosisinduced Aggression or Agitation (Rapid Tranquillisation)

The evidence is insufficient for the efficacy of risperidone for psychosis-induced aggression or agitation. Level of evidence: "D"

Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment), imprecise results (few small studies for each comparison) and indirectness (differences in outcomes).

Summary

A Cochrane review [Abstract] 1 included 9 studies with a total of 582 subjects. A total of 89% of the patients had a diagnosis of schizophrenia. None of the included studies provided data on the primary outcome 'tranquillisation or asleep' by 30 minutes, repeated need for tranquillisation or any economic outcomes.

  • Risperidone vs. haloperidol (up to 24 hours follow-up): For the outcome, specific behaviour-agitation, no clear difference was found between risperidone and haloperidol in terms of efficacy, measured as at least 50% reduction in the Positive and Negative Syndrome Scale-Psychotic Agitation Sub-score (PANSS-PAS) (RR 1.04, 95% CI 0.86 to 1.26; 1 study, n = 124) and no effect was observed for need to use restraints (RR 2.00, 95% CI 0.43 to 9.21; 1 study, n = 28). Incidence of adverse effects was similar between treatment groups (RR 0.94, 95% CI 0.54 to 1.66; 1 study, n = 124).
  • Risperidone vs. olanzapine: No effect was observed for agitation measured as PANSS-PAS endpoint score at 2 hours (MD 2.50, 95% CI -2.46 to 7.46; 1 study, n=29); need to use restraints at 4 days (RR 1.43, 95% CI 0.39 to 5.28; 1 study, n=29); specific movement disorders measured as Behavioural Activity Rating Scale (BARS) endpoint score at 4 days (MD 0.20, 95% CI -0.43 to 0.83; 1 study, n=29).
  • Risperidone vs. quetiapine: Aggression was measured using the Modified Overt Aggression Scale (MOAS) endpoint score at 2 weeks. A clear difference favouring quetiapine was observed (MD 1.80, 95% CI 0.20 to 3.40; 1 study, n=40). No evidence of a difference between treatment groups could be observed for incidence of akathisia after 24 hours (RR 1.67, 95% CI 0.46 to 6.06; 1 study, n=40). Two participants allocated to risperidone and one allocated to quetiapine experienced myocardial ischaemia during the trial.
  • Risperidone vs. risperidone + oxcarbazepine: When agitation was measured using the Positive and Negative Syndrome Scale -Excited Component (PANSS-EC) endpoint score, it favoured the combination treatment at one week (MD 2.70, 95% CI 0.42 to 4.98; 1 study, n=68), but no effect was observed for global state using Clinical Global Impression - Improvement (CGI-I) endpoint score at one week (MD -0.20, 95% CI -0.61 to 0.21; 1 study, n=68). Incidence of extrapyramidal symptoms after 24 hours was similar between treatment groups (RR 1.59, 95% CI 0.49 to 5.14).
  • Risperidone vs. risperidone + valproic acid: No clear differences between the treatment groups were observed for aggression (MOAS endpoint score at 3 days: MD 1.07, 95% CI -0.20 to 2.34; one study, n = 54) or incidence of akathisia after 24 hours: RR 0.75, 95% CI 0.28 to 2.03; participants = 122; studies = 2; n=122).

Clinical comments

Note

Date of latest search:

    References

    • Ostinelli EG, Hussein M, Ahmed U et al. Risperidone for psychosis-induced aggression or agitation (rapid tranquillisation). Cochrane Database Syst Rev 2018;4():CD009412. [PubMed]

Primary/Secondary Keywords