ANDREA-LD

• Research type

  Research Study

• Full title

  'Community led ANti-psychotic Drug REduction for Adults with Learning Disabilities (ANDREA-LD): A Randomised Double-blind Placebo Controlled Trial'

• IRAS ID

  123966

• Contact name

  Michael Kerr

• Sponsor organisation

  Cardiff University, Research and Commercial Division

• Eudract number

  2013-000389-12

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  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 research will address 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medication prescribed to adults with learning disabilities for the treatment of challenging behaviour can be withdrawn or reduced without behaviour or mental health deteriorating and treatment costs escalating.This is a 2 arm randomised double-blind placebo-controlled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. Intervention participants will proceed through 4 monthly approximately 25% reduction stages within a 6 month period.  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.We will recruit 310 adults with learning disabilities (LD) prescribed either 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.After an initial recruitment pilot phase, recruitment will continue in 3 waves. Participants will be assessed at 6, 9 and 12 months from randomisation.

• REC name

  Wales REC 3

• REC reference

  13/WA/0034

• Date of REC Opinion

  4 Apr 2013

• REC opinion

  Further Information Favourable Opinion