ArticlesRisperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial
Introduction
People with intellectual disability often have poor resilience to adversity, and their ability to deal with stresses is also limited. One of the most common results of this limitation is the response of aggression and related challenging behaviour. Such behaviour is common, with a prevalence ranging from 16% to more than 50% depending on definition;1, 2, 3 yet despite behaviour being used frequently as a clinical diagnosis it has no formal diagnostic status, and no clear connections to psychotic illness.4
Since the earliest report of the efficacy of antipsychotic (neuroleptic) drugs in this population,5 the use of these drugs has become commonplace, with between 22% and 45% of people with intellectual disability in hospital and about 20% of those in the community being prescribed antipsychotic drugs.6, 7, 8 These figures are very high considering that the prevalence of psychiatric illness in intellectual disability, which in previous studies has ranged from 28% to 46%,7, 9 falls to less than 15% when the pseudodiagnosis of problem behaviours is removed.4 The difference in these figures suggests either that some of the antipsychotic drugs prescribed for people with intellectual disability are given for behavioural disturbance without underlying psychiatric illness, or that challenging behaviour ought to be regarded as an important diagnosis in its own right.
Despite the widespread use of antipsychotic drugs to treat challenging behaviour, the evidence base is scarce. A systematic review of antipsychotic drugs for the treatment of people with both challenging behaviour and intellectual disability found eight randomised controlled trials of antipsychotic drugs versus placebo but concluded that these studies “provided no evidence of whether antipsychotic medication helps or harms adults with intellectual disability and challenging behaviour”.10 The NACHBID (Neuroleptics for Aggressive CHallenging Behaviour in Intellectual Disability) clinical trial was designed to remedy this deficiency by comparing the effects of first-generation and second-generation antipsychotic drugs with placebo in people with intellectual disability who have shown disruptive behaviour.
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Study design and patients
The study was a three-arm, parallel-group pragmatic trial of placebo, haloperidol, and risperidone with balanced randomisation, but no stratification, into each arm, and blind assessments of outcome at 4, 12, and 26 weeks after randomisation. The main null hypothesis was that there were no differences between the effects of a typical antipsychotic drug (haloperidol), an atypical antipsychotic drug (risperidone), and placebo in reduction of aggression, when flexible doses of the drugs were given
Results
Figure 1 shows the trial profile. Of 180 eligible participants, 86 were randomly assigned to treatment groups. Table 1 shows the baseline characteristics, which were much the same between groups. Patients were predominantly men, and most had mild or moderate intellectual disability (table 1). At the fourth week of the study only one patient (assigned to placebo) had any missing data, and of the weekly MOAS assessments only three (different patients) of the 344 assessments were missing between
Discussion
Our multicentre study has compared first-generation and second-generation antipsychotic drugs with placebo in patients with aggressive challenging behaviour. Although we noted a reduction in aggression with all treatments after 4 weeks, the greatest decrease was with placebo. Furthermore, we recorded no differences between groups in terms of aberrant behaviour, quality of life, general improvement, effect on carers, and adverse drug effects.
Our results differ from those of Van den Borre and
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