TY  - BOOK
AU  - Asherson,P
AU  - Johansson,L
AU  - Holland,R
AU  - Bedding,M
AU  - Forrester,A
AU  - Giannulli,L
AU  - Ginsberg,Y
AU  - Howitt,S
AU  - Kretzschmar,I
AU  - Lawrie,SM
AU  - Marsh,C
AU  - Kelly,C
AU  - Mansfield,M
AU  - McCafferty,C
AU  - Khan,K
AU  - Muller-Sedgwick,U
AU  - Strang,J
AU  - Williamson,G
AU  - Wilson,L
AU  - Young,S
AU  - Landau,S
AU  - Thomson,L
TI  - 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)
PY  - 2023///-01
KW  - Text
KW  - local
N1  - /pmc/articles/PMC7613969; /pubmed/35657651
N2  - 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 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 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 and 47.9% for the placebo arm. No statistically significant trial arm differences 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 27(th) August 2019
UR  - http://dx.doi.org/10.1192/bjp.2022.77
ER  -