Community led ANti-psychotic Drug REduction for Adults with Learning Disabilities: A Randomised Double-blind Placebo Controlled Trial.
Approximately 1 in 200 adults are recognised as having a learning disability. Illness in this population is high, including significant rates of challenging behaviour and mental illness. Use of psychoactive medication is high and there is particular concern over the use of anti-psychotic medication that is prescribed for reasons other than the treatment of psychosis. Control of challenging behaviour is the primary reason why such medications are prescribed despite the absence of good evidence for any therapeutic effect for this purpose. This problem is central to the intervention being evaluated in this trial.
The central research question to be addressed was whether anti-psychotic medication prescribed to adults with learning disabilities for the treatment of challenging behaviour could be withdrawn or reduced without behaviour or mental health deteriorating and treatment costs escalating.
This was an exploratory pilot study. We recruited adults with learning disabilities (LD) identified through practice LD registers prescribed the anti-psychotic medication risperidone for treatment of challenging behaviour with no known current psychosis or previous recurrence of psychosis following prior drug reduction.
This was a 2 arm randomised double-blind placebo-controlled non-inferiority withdrawal trial. Treatment was supported by a specially designed trial specific treatment and safety package. During the trial, those in the intervention arm proceeded through up to 4 monthly reduction stages within a 6 month period (although blinded, the PI had discretion to delay progression to the next step). Each reduction was approximately 25% of the starting dose. The control group will maintain baseline treatment. Treatment achieved at 6 months was maintained for a further 3 months under blind conditions. At 9 months, the blinding was broken for clinicians and participants.
This was a unique design of a drug withdrawal programme which allowed medication to remain blinded through the trial.
We recruited around 310 adults with learning disabilities (LD) identified through practice LD registers prescribed one of two anti-psychotic drugs (risperidone or haloperidol) for treatment of challenging behaviour with no known current psychosis or previous recurrence of psychosis following prior drug reduction.
The primary outcome is level of aggression as measured by the Modified Overt Aggression Scale (MOAS). Secondary outcomes are other challenging behaviour, mental health, adverse effects of psychotropic medication, movement disorders, cost estimates and percentage change in medication.
Involving the public and patients
A parent of an adult with a learning disability became a member of the Trial Steering Committee.
|Start date||1 Oct 2013|
|End date||31 Dec 2016|