Randomised controlled trial of the short-term effects of osmotic-release oral system methylphenidate on symptoms and behavioural outcomes in young male prisoners with attention deficit hyperactivity disorder: CIAO-II study

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

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

Background
Research has shown that 20–30% of prisoners meet the diag-
nostic criteria for attention-deficit hyperactivity disorder (ADHD).
Methylphenidate reduces ADHD symptoms, but effects in pris-
oners are uncertain because of comorbid mental health and
substance use disorders.
Aims
To estimate the efficacy of an osmotic-release oral system
methylphenidate (OROS-methylphenidate) in reducing ADHD
symptoms in young adult prisoners with ADHD.
Method
We conducted an 8-week parallel-arm, double-blind, rando-
mised placebo-controlled trial of OROS-methylphenidate versus
placebo in male prisoners (aged 16–25 years) meeting the 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 outcomes were measured,
including emotional dysregulation, mind wandering, violent atti-
tudes, mental health symptoms, and prison officer and educa-
tional staff ratings of behaviour and aggression.
Results
In the OROS-methylphenidate arm, mean CAARS-O score at 8
weeks 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 score,
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, multi-modal treatments and
preventative interventions in the community.
Original languageEnglish
Number of pages11
JournalBritish Journal of Psychiatry
Early online date3 Jun 2022
DOIs
Publication statusE-pub ahead of print - 3 Jun 2022

Keywords / Materials (for Non-textual outputs)

  • Prisoners
  • methylphenidate
  • randomised controlled trial
  • attention-deficit hyperactivity disorders
  • forensic mental health services

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