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ANDREA-LD

ANti-psychotic Drug REduction in primary care for Adults with Learning Disabilities

A Randomised Double-blind Placebo Controlled Trial

Background

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.

Aim

The central research question to be addressed is whether anti-psychotic medication prescribed to adults with learning disabilities for the treatment of challenging behaviour can be withdrawn or reduced without behaviour or mental health deteriorating and treatment costs escalating.

Design

A 2 arm randomised double-blind placebo-controlled non-inferiority withdrawal trial. Treatment will be primary care led and will be supported by a specially designed trial specific treatment and safety package. During the trial, those in the intervention arm will proceed through 4 monthly approximately 25% reduction stages within a 6 month period (although blinded, the GP has discretion to delay progression to the next step). The control group will maintain baseline treatment. Treatment achieved at 6 months will be maintained for a further 3 months under blind conditions. At 9 months, the blinding will be broken for clinicians and participants and medication changes monitored over the 12 month period from baseline.

Population

We will recruit 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.

Outcome measures

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.

Duration and follow-up

After an initial recruitment pilot phase, recruitment will continue in waves. There will be 3 waves in total resulting in continuous recruitment. Participants will be assessed at 6, 9 and 12 months from randomisation.

Study Type

Randomised controlled Trial

Study Status

Open

Funder

National Institute of Health Research Health Technology Assessment Programme (NIHR HTA)

Study Team

Dr Rachel McNamara (Senior Trial Manager), Elizabeth Randell (Trial Manager), Aude Espinasse (Data Manager), Jackie Swain and Christian Barlow (Research Administrators), David Gillespie (Statistician), Miguel Cossio (Database Programmer)

Key data

Status
Running
Start date
Oct. 1, 2013
End date
Dec. 31, 2016
Grant value
£1,445,854
General enquiries
Miss Elizabeth Randell
Chief investigators
Prof Michael Kerr

External links

Related pages