Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial

Tyrer, Peter, Oliver-Africano, Patricia C., Ahmed, Zed, Bouras, Nick, Cooray, Sherva, Deb, Shoumitro, Murphy, Declan, Hare, Monica, Meade, Michael, Reece, Ben, Kramo, Kofi, Bhaumik, Sabyasachi, Harley, David, Regan, Adrienne, Thomas, David, Rao, Bharti, North, Bernard, Eliahoo, Joseph, Karatela, Shamshad, Soni, Anju and Crawford, Mike (2008) Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial. The Lancet, 371 9606: 57-63. doi:10.1016/S0140-6736(08)60072-0


Author Tyrer, Peter
Oliver-Africano, Patricia C.
Ahmed, Zed
Bouras, Nick
Cooray, Sherva
Deb, Shoumitro
Murphy, Declan
Hare, Monica
Meade, Michael
Reece, Ben
Kramo, Kofi
Bhaumik, Sabyasachi
Harley, David
Regan, Adrienne
Thomas, David
Rao, Bharti
North, Bernard
Eliahoo, Joseph
Karatela, Shamshad
Soni, Anju
Crawford, Mike
Title Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial
Journal name The Lancet   Check publisher's open access policy
ISSN 0140-6736
Publication date 2008-01-05
Year available 2008
Sub-type Article (original research)
DOI 10.1016/S0140-6736(08)60072-0
Open Access Status
Volume 371
Issue 9606
Start page 57
End page 63
Total pages 7
Editor Richard Horton
Place of publication London, UK
Publisher The Lancet Publishing Group
Language eng
Subject 920401 Behaviour and Health
920403 Disability and Functional Capacity
111703 Care for Disabled
170101 Biological Psychology (Neuropsychology, Psychopharmacology, Physiological Psychology)
C1
Abstract Background Aggressive challenging behaviour is frequently reported in adults with intellectual disability and it is often treated with antipsychotic drugs. However, no adequate evidence base for this practice exists. We compared fl exible doses of haloperidol (a typical, fi rst generation antipsychotic drug), risperidone (an atypical, second-generation antipsychotic), and placebo, in the treatment of this behaviour. Methods 86 non-psychotic patients presenting with aggressive challenging behaviour from ten centres in England and Wales, and one in Queensland, Australia, were randomly assigned to haloperidol (n=28), risperidone (n=29), or placebo (n=29). Clinical assessments of aggression, aberrant behaviour, quality of life, adverse drug eff ects, and carer uplift (positive feelings about the care of the disabled person) and burden, together with total costs, were recorded at 4, 12, and 26 weeks. The primary outcome was change in aggression after 4 weeks’ treatment, which was recorded with the modifi ed overt aggression scale (MOAS). Analysis was by intention to treat. This study is registered as ISRCTN 11736448. Findings 80 patients had adherence of 80% or more to prescribed drug. Aggression decreased substantially with all three treatments by 4 weeks, with the placebo group showing the greatest change (median decrease in MOAS score after 4 weeks=9 [95% CI 5–14] for placebo, 79% from baseline; 7 [4–14] for risperidone, 58% from baseline; 6·5 [5–14] for haloperidol, 65% from baseline; p=0·06). Furthermore, although no important diff erences between the treatments were recorded, including adverse eff ects, patients given placebo showed no evidence at any time points of worse response than did patients assigned to either of the antipsychotic drugs. Interpretation Antipsychotic drugs should no longer be regarded as an acceptable routine treatment for aggressive challenging behaviour in people with intellectual disability.
Keyword Risperidone
Haloperidol
challenging behaviour
intellectual disability
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Available online 3 January 2008.

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2009 Higher Education Research Data Collection
School of Public Health Publications
School of Medicine Publications
 
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Created: Fri, 27 Mar 2009, 22:34:39 EST by Dell Hele on behalf of School of Medicine