Overcoming the barriers experienced in conducting a medication trial in adults with aggressive challenging behaviour and intellectual disabilities.

Imperial College London, Dept. of Psychological Medicine, UK.
Journal of Intellectual Disability Research (Impact Factor: 2.41). 08/2009; 54(1):17-25. DOI: 10.1111/j.1365-2788.2009.01195.x
Source: PubMed

ABSTRACT Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base.
A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs (risperidone and haloperidol) and placebo.
The trial faced significant problems in recruitment. The intent was to recruit 120 patients over 2 years in three centres and to use a validated aggression scale (Modified Overt Aggression Scale) score as the primary outcome. Despite doubling the period of recruitment, only 86 patients were ultimately recruited.
Variation in beliefs over the efficacy of drug treatment, difficulties within multidisciplinary teams and perceived ethical concerns over medication trials in this population all contributed to poor recruitment. Where appropriate to the research question cluster randomised trials represent an ethically and logistically feasible alternative to individually randomised trials.

  • [Show abstract] [Hide abstract]
    ABSTRACT: Pharmacotherapy is a frequently employed treatment option in the area of autism spectrum disorders (ASD). A considerable literature base has developed indicating when these medications should or could be administered. However, research on the potential side effects and cost benefit analysis of these treatments is not well understood at this time. The purpose of this review is to assess current prescription practices, to determine what is needed with respect to better understanding the cost and benefits of these prescription practices, and notions about future trends in research to better aid in our understanding of psychotropic drug side effects. Future research of this sort should further establish best practices with respect to pharmacotherapy and ASD.
    Research in Autism Spectrum Disorders 01/2011; 5(1):230–236. · 2.96 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Loss of cortical volume in frontotemporal regions occurs in patients with first-episode psychosis (FEP) and longitudinal studies have reported progressive brain volume changes at different stages of the disease, even if cognitive deficits remain stable over time. We investigated cortical changes in patients over the 2 years following their FEP and their associations with clinical and cognitive measures.
    Psychological Medicine 07/2014; · 5.43 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The management of problem behaviours (PB) in individuals with intellectual disabilities (ID), developmental disabilities (DD) and/or autistic spectrum disorders (ASD) can be challenging. Antipsychotic medications are commonly prescribed where other strategies have failed. A systematic review (SR) was conducted to establish the research evidence for the efficacy of aripiprazole in the management of PB in adults and children with ID, DD and/or ASD. Although included studies supported the efficacy of aripiprazole for this indication, the overall quality of studies was poor. Of the 20 studies included in this systematic review there were only two randomised controlled trials (RCTs) on children with ASD and/or ID/DD, both of which were conducted by the pharmaceutical company that manufactures aripiprazole, and it is not clear whether a number of same participants were included in both RCTs. One of the RCTs was extended into an open label long term follow up, which showed that aripiprazole's efficacy lasted over 52 weeks and the adverse effects were tolerable. Four studies were open label prospective studies, 11 were retrospective case reports which included four single case reports, and two were prospective case series. Most studies reported adverse effects from aripiprazole in the form of weight gain, increased appetite, sedation, tiredness, drooling and tremor. However, aripiprazole improved serum prolactin level in some participants and overall did not show any adverse effect on QTc interval. There is a need for more carefully designed RCTs into the use of aripiprazole in the management of PB in people with ID/DD and/or ASD, which should be carried out independent of pharmaceutical companies.
    Research in developmental disabilities 01/2014; · 4.41 Impact Factor


Available from
Jul 25, 2014