Off-label use of risperidone in people with intellectual disability: A discontinuation study

Often people with intellectual disability use antipsychotics, including risperidone, for the treatment of challenging behavior. This use of risperidone is off-label, often long-term and can cause many side-effects. For that reason we will test the effectiveness of risperidone after long-term use in challenging behavior. This study is a placebo-controlled discontinuation study of risperidone, in which the effect of discontinuation is tested on behavior, health and quality of life.

We expect that it is possible to discontinue long-term (>1 year) used risperidone prescribed for challenging behaviors in people with intellectual disability without a clinical relevant change in behavior. Furthermore, as a result of discontinuation we expect that health outcomes will improve, such as weight, cholesterol levels, prolactin levels and neurological symptoms (extrapyramidal symptoms and autonomic symptoms). As a result we also expect quality of life to improve after discontinuation of risperidone.

week 0: baseline measurements

week 2: start discontinuation

week 6, 10, 14: measurements during discontinuation

week 16: end of discontinuation

week 18 and 24: blinded follow-up measurements

week 24: end of blinded phase

week 42: naturalistic follow-up

the intervention group will gradually discontinue the use of risperidone to placebo. The control group will continue the use of risperidone on their normal dose