CIAO-II Version 1.0
Randomised controlled trial of the short term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention deficit hyperactivity disorder
Philip J Asherson
King's College London
Duration of Study in the UK
3 years, 0 months, 0 days
An 8-week parallel arm randomised placebo controlled trial of an extended release formulation of methylphenidate (OROS-MPH) on ADHD symptoms, behaviour and functional outcomes in young male offenders with ADHD aged 16-25. Participants will be randomised to a 8-weeks treatment with either OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. 200 participants will be recruited with 1:1 ratio of drug to placebo. Randomisation conducted by the King’s CTU with blinding of both investigators and participants. Randomisation is stratified by site and automated using online system. OROS-MPH will be offered to both the OROS-MPH and placebo treated groups as part of their clinical care once the 8-week trial is completed.
The primary outcome measure is the level of ADHD symptoms measured on the investigator rated Connors Adult ADHD Rating Scale (CAARS) to answer the question of efficacy of OROS-MPH on ADHD symptoms in young offenders meeting clinical criteria for ADHD. CAARS is one of the main outcome measures used in previous treatment trials of ADHD in the community.
Secondary outcomes address important questions about the effects on comorbid symptoms and behavioural impairments that are commonly seen in offenders with ADHD. These include: emotional dysregulation, prison records of behaviour, such as antisocial behaviour and rule breaking, ratings of aggressive behaviour by prison staff and positive engagement with the prison occupational, educational and rehabilitation programs.
Further exploratory analyses will test the hypothesis that changes in symptoms of ADHD explain changes in positive and negative behaviour.
East of England - Essex Research Ethics Committee
Date of REC Opinion
31 May 2016
Further Information Favourable Opinion