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: CIAO-II study

Philip Asherson, Lena Johansson, Rachel Holland, Megan Bedding, Andrew Forrester, Gianulli Laura, Ylva Ginsberg, Sheila Howitt, Imogen Kretzschmar, Stephen Lawrie, Craig Marsh, Caroline Kelly, Megan Mansfield, Clare McCafferty, Khuram Khan, Ulrich Muller-Sedgwick, John Strang, Grace Williamson, Lauren Wilson, Susan YoungSabine Landau, Lindsay Thomson

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Abstract

Abstract (237/300 words)
Background: 20-30% of prisoners meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD). Methylphenidate reduces ADHD symptoms but effects in prisoners are uncertain due to 16 comorbid mental health and substance use disorders.

Aim: To estimate the efficacy of an Osmotic-Release-Oral-System methylphenidate (OROS-methylphenidate) in reducing ADHD symptoms in young adult prisoners with ADHD.

Methods: An 8-week parallel arm, double-blind, randomised, placebo-controlled trial of OROS-methylphenidate versus placebo in male prisoners (aged 16-25) meeting DSM-5 criteria for ADHD. Primary outcome was ADHD symptoms at 8-weeks using the investigator rated Connors Adult ADHD Rating Scale (CAARS-O). Thirteen secondary outcome measures included emotional dysregulation, mind-wandering, violent attitudes, mental health symptoms, and prison officer and educational staff ratings of behaviour and aggression.

Findings: Mean CAARS-O at 8 weeks in the OROS-methylphenidate arm was estimated to be reduced 26 by 0.57 points relative to the Placebo arm (95% CI: -2.41 to 3.56) and non-significant. The responder rate, defined as a 20% reduction in CAARS-O scores was 48.3% for the OROS-methylphenidate arm
28 and 47.9% for the placebo arm. No statistically significant trial arm difference were detected for any of the secondary outcomes. Mean final titrated dose was 53.8 mg in the OROS-methylphenidate arm.

Conclusions: ADHD symptoms did not respond to OROS-methylphenidate in young adult prisoners. The findings do not support routine treatment with OROS-methylphenidate in this population. Further research is needed to evaluate effects of higher average dosing and adherence to treatment, multimodal treatments, and preventative interventions in the community.

Trial registration: EudraCT Number 2015-004271-78; ISRCTN16827947. Database lock 27th August 2019
Original languageEnglish
Pages (from-to)1
Number of pages11
JournalBritish Journal of psychiatry
Early online date3 Jun 2022
DOIs
Publication statusPublished - 3 Jun 2022

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