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Meta-Analysis
. 2018 Apr 10;4(4):CD009412.
doi: 10.1002/14651858.CD009412.pub2.

Risperidone for psychosis-induced aggression or agitation (rapid tranquillisation)

Edoardo G Ostinelli  1 , Mohsin Hussein, Uzair Ahmed, Faiz-Ur Rehman, Krista Miramontes, Clive E Adams
Affiliations
Meta-Analysis

Risperidone for psychosis-induced aggression or agitation (rapid tranquillisation)

Edoardo G Ostinelli et al. Cochrane Database Syst Rev. .

Abstract

Background: Aggressive, agitated or violent behaviour due to psychosis constitutes an emergency psychiatric treatment where fast-acting interventions are required. Risperidone is a widely accessible antipsychotic that can be used to manage psychosis-induced aggression or agitation.

Objectives: To examine whether oral risperidone alone is an effective treatment for psychosis-induced aggression or agitation.

Search methods: We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (up to April 2017); this register is compiled by systematic searches of major resources (including AMED, BIOSIS CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings. There are no language, date, document type, or publication status limitations for inclusion of records into the register.

Selection criteria: Randomised controlled trials (RCTs) comparing rapid use of risperidone and other drugs, combinations of drugs or placebo for people exhibiting aggression or agitation (or both) thought to be due to psychosis.

Data collection and analysis: We independently inspected all citations from searches, identified relevant abstracts, and independently extracted data from all included studies. For binary data we calculated risk ratio (RR) and for continuous data we calculated mean difference (MD), all with 95% confidence intervals (CI) and used a fixed-effect model. We assessed risk of bias for the included studies and used the GRADE approach to produce a 'Summary of findings' tables.

Main results: The review now contains data from nine trials (total n = 582) reporting on five comparisons. Due to risk of bias, small size of trials, indirectness of outcome measures and a paucity of investigated and reported 'pragmatic' outcomes, evidence was graded as very-low quality. None of the included studies provided useable data on our primary outcome 'tranquillisation or asleep' by 30 minutes, repeated need for tranquillisation or any economic outcomes. Data were available for our other main outcomes of agitation or aggression, needing restraint, and incidence of adverse effects.Risperidone versus 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; participants = 124; studies = 1; very low-quality evidence) and no effect was observed for need to use restraints (RR 2.00, 95% CI 0.43 to 9.21; participants = 28; studies = 1; very low-quality evidence). Incidence of adverse effects was similar between treatment groups (RR 0.94, 95% CI 0.54 to 1.66; participants = 124; studies = 1; very low-quality evidence).Risperidone versus olanzapineOne small trial (n = 29) reported useable data for the comparison risperidone versus olanzapine. No effect was observed for agitation measured as PANSS-PAS endpoint score at two hours (MD 2.50, 95% CI -2.46 to 7.46; very low-quality evidence); need to use restraints at four days (RR 1.43, 95% CI 0.39 to 5.28; very-low quality evidence); specific movement disorders measured as Behavioural Activity Rating Scale (BARS) endpoint score at four days (MD 0.20, 95% CI -0.43 to 0.83; very low-quality evidence).Risperidone versus quetiapineOne trial reported (n = 40) useable data for the comparison risperidone versus quetiapine. Aggression was measured using the Modified Overt Aggression Scale (MOAS) endpoint score at two weeks. A clear difference, favouring quetiapine was observed (MD 1.80, 95% CI 0.20 to 3.40; very-low quality evidence). 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; very low-quality evidence). Two participants allocated to risperidone and one allocated to quetiapine experienced myocardial ischaemia during the trial.Risperidone versus risperidone + oxcarbazepineOne trial (n = 68) measured agitation using the Positive and Negative Syndrome Scale - Excited Component.(PANSS-EC) endpoint score and found a clear difference, favouring the combination treatment at one week (MD 2.70, 95% CI 0.42 to 4.98; very low-quality evidence), 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; very-low quality evidence). Incidence of extrapyramidal symptoms after 24 hours was similar between treatment groups (RR 1.59, 95% CI 0.49 to 5.14; very-low quality evidence).Risperidone versus risperidone + valproic acidTwo trials compared risperidone with a combination of risperidone plus valproic acid. No clear differences between the treatment groups were observed for aggression (MOAS endpoint score at three days: MD 1.07, 95% CI -0.20 to 2.34; participants = 54; studies = 1; very low-quality evidence) or incidence of akathisia after 24 hours: RR 0.75, 95% CI 0.28 to 2.03; participants = 122; studies = 2; very low-quality evidence).

Authors' conclusions: Overall, results for the main outcomes show no real effect for risperidone. The only data available for use in this review are from nine under-sampled trials and the evidence available is of very low quality. This casts uncertainty on the role of risperidone in rapid tranquillisation for people with psychosis-induced aggression. High-quality pragmatic RCTs are feasible and are needed before clear recommendations can be drawn on the use of risperidone for psychosis-induced aggression or agitation.

PubMed Disclaimer

Conflict of interest statement

Edoardo G Ostinelli: none known.

Mohsin Hussein: none known.

Uzair Ahmed: none known.

Faiz‐ur Rehman: none known.

Krista Miramontes: none known.

Clive E Adams: none known.

Figures

1
1
Risperidone structure
2
2
Search results ‐ up to April 2017
3
3
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Conde 2011 {published data only}
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Currier 2000 {published data only}
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Currier 2004 {published data only}
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Czobor 1995 {published data only}
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Han 2005 {published data only}
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Hatta 2008 {published data only}
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Hong 2014 {published data only}
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Hou 2011 {published data only}
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Hovens 2005 {published data only}
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ISRCTN11736448 2003 {published data only}
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Jiang 2012 {published data only}
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Kane 2003 {published data only}
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Kirwan 2002 {published data only}
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Kolivakis 2002 {published data only}
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Lewis 2006 {published data only}
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Li 2014 {published data only}
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Lieberman 2001 {published data only}
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Liu 2010 {published data only}
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Liu 2012 {published data only}
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NCT00174200 2005 {published data only}
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NCT00203775 2005 {published data only}
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NCT00205699 2005 {published data only}
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NCT00418873 2007 {published data only}
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NCT00485498 2003 {published data only}
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Ou 2007 {published data only}
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Pei 2009 {published data only}
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Peng 2009 {published data only}
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Potkin 2005 {published data only}
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Schooler 2003 {published data only}
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Swanson 2008 {published data only}
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Tang 2007 {published data only}
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Temputrn 2007 {published data only}
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Tosic Golubovic Suzana 2009 {published data only}
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Veser 2006 {published data only}
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Villari 2008 {published data only}
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Wan 2005 {published data only}
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Wang 2004 {published data only}
    1. Wang G, Cai ZJ, Wang LF. A multicenter study of risperidone treatment for acute agitation in patients with schizophrenia. Chinese Journal of Psychiatry 2004;37(2):88‐91.
Wang 2006 {published data only}
    1. Wang H. Therapeutic effect of risperidone combined with magnesium valproate in aggressive behaviors of schizophrenics. Chinese Journal of Health Psychology 2006;14(4):441‐2.
Wang 2015 {published data only}
    1. Wang CD. Observation of curative effect of electroconvulsive therapy in treatment of aggressive behaviour in Schizophrenia [无抽搐电休克治疗精神分裂症暴力攻击行为疗效观察]. Journal of Clinical Psychosomatic Diseases [临床心身疾病杂志] 2015;21(6):117‐8.
Wei 2010 {published data only}
    1. Wei SZ. Olanzapine and risperidone in adolescent schizophrenia starting control study of 60 cases. Medical Journal of Chinese Peoples Health 2010;22(11):1414‐5.
Xi 2010 {published data only}
    1. Xi MA. A study of additive effect of magnesium valproate in the treatment of schizophrenia. Chinese Journal of Practical Medicine 2010;5(12):43‐4.
Xuan 2007 {published data only}
    1. Xuan GH, Chu Y. Clinical observation on the effect of risperidone combined with BZD on schizophrenia. China Tropical Medicine 2007;7(2):244.
Zhang 2012 {published data only}
    1. Zhang QE, Wang G, Zhang L, Wang X, Luo J, Lu YZ, et al. Controlled study of risperidone oral solution in combination with clonazepam tablets for acute agitation in schizophrenia [利培酮口服液合并氯硝西泮片治疗精神分裂症急性激越的对照研究]. The 10th National Conference of Psychiatry [中华医学会第十次全国精神医学学术会议] 2012;22(02):89‐91.
Zheng 2010 {published data only}
    1. Zheng C, Suoyu Z, Hui W, Ying Q, Yan W, Yun X, et al. Randomized controlled study of psychotic agitation in schizophrenic patients comparing combination treatment with oral risperidone and clonazepam versus initial treatment with intramuscular haloperidol followed by oral risperidone. Shandong Archives of Psychiatry 2010;22(6):354‐7.
Zhou 2012 {published data only}
    1. Zhou DX, Jiang XY, Xu Q, Fang XY, Xia MH, Lu YN. A randomized controlled study of risperidone oral solution combined with clonazepam in the treatment of schizophrenic symptoms [利培酮口服液合并氯硝西泮治疗精神分裂症兴奋激越症状的随机对照研究]. Chinese Journal of Health Psychology [中国健康心理学杂志] 2012;8:1123‐4.

References to studies awaiting assessment

Herrera 2005 {published data only}
    1. Herrera M. Double blind study with risperidone vs haloperidol in schizophrenic patients with agitation and/or aggression. 8th World Congress of Psychiatry; 2005 Sep 10‐15; Cairo, Egypt. 2005.
Hsu 2010 {published data only}
    1. Hsu WY, Huang SS, Lee BS, Chiu NY. Comparison of intramuscular olanzapine, orally disintegrating olanzapine tablets, oral risperidone solution, and intramuscular haloperidol in the management of acute agitation in an acute care psychiatric ward in Taiwan. Journal of Clinical Psychopharmacology 2010;30(3):230‐4. - PubMed
Lasic 2006 {published data only}
    1. Lasic D, Rubesa G, Dodig G, Katavic Z, Glavina T, Zuljan‐Cvitanovic M. Risperidone oral solution, therapeutic possibility in treatment of acute and agitated psychotic patients. European Neuropsychopharmacology 2006;16(Suppl 4):S445.
NCT00859872 {published data only}
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References to other published versions of this review

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