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Long-term use of risperidone

Efficacy in people with intellectual disabilities

Status
Analysis

Antipsychotics such as risperidone are prescribed frequently and for prolonged periods for people with intellectual disabilities. Almost no research has been conducted to assess the long-term efficacy of such medication. This research study examines the long-term efficacy of risperidone use for behavioural problems experienced by children, adolescents and adults with intellectual disabilities.

Background

Antipsychotics are used to treat psychotic disorders and schizophrenia, and can also be used for behavioural problems such as severe aggression or agitation in people with intellectual disabilities. Risperidone is particularly often prescribed in the event of behavioural problems, especially for children and adolescents. Various research studies have been conducted to investigate risperidone’s short-term effects. However, almost no research has been done in relation to its long-term efficacy. We do know, though, that risperidone can have adverse side-effects and can therefore impact on quality of life.

The research study

We are researching the long-term efficacy of risperidone prescribed for behavioural problems in children aged 5 years and over, and in adolescents and adults with intellectual disabilities (IQ below 70). We are doing this by means of a double-blind, placebo-controlled tapering study. Participants are allocated to either the tapering group or the control group. In the tapering group, the risperidone dose is gradually tapered and eventually replaced by a placebo.

Participants do not know to which group they have been allocated. Everyone is given the product in liquid form. All participants start with bottle A, which contains risperidone, and gradually switch over to bottle B, which contains either risperidone or a placebo. Throughout this trajectory, participants’ behaviour, side effects and quality of life are monitored by means of questionnaires and brief physical examinations.

Collaboration

For this research study, Accare researchers are collaborating with the Drenthe Mental Health Service (GGZ).