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 Young; Sabine Landau; Lindsay D. G. Thomson

doi:10.1192/bjp.2022.77

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 journal › Article › peer-review

Abstract

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 language	English
Number of pages	11
Journal	British Journal of Psychiatry
Early online date	3 Jun 2022
DOIs	https://doi.org/10.1192/bjp.2022.77
Publication status	E-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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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 (ADHD): CIAO-II study: commentary, Asherson et al
Asherson, P., Forrester, A., Johansson, L. & Thomson, L., 4 Nov 2024, (E-pub ahead of print) In: The British journal of psychiatry : the journal of mental science. 225, 3, p. 412-413 2 p.
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Asherson, P. J., Johansson, L., Holland, R., Bedding, M., Forrester, A., Giannulli, L., Ginsberg, Y., Howitt, S., Kretzschmar, I., Lawrie, S. M., Marsh, C., Kelly, C., Mansfield, M., McCafferty, C., Khan, K., Muller-Sedgwick, U., Strang, J., Williamson, G., Wilson, L., ... Thomson, L. D. G. (2022). 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. British Journal of Psychiatry. Advance online publication. https://doi.org/10.1192/bjp.2022.77

@article{5b8908d5ab164f1aa567791705eae615,

title = "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",

abstract = "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.",

keywords = "Prisoners, methylphenidate, randomised controlled trial, attention-deficit hyperactivity disorders, forensic mental health services",

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

year = "2022",

month = jun,

day = "3",

doi = "10.1192/bjp.2022.77",

language = "English",

journal = "British Journal of Psychiatry",

issn = "0007-1250",

publisher = "Cambridge University Press",

}

Asherson, PJ, Johansson, L, Holland, R, Bedding, M, Forrester, A, Giannulli, L, Ginsberg, Y, Howitt, S, Kretzschmar, I, Lawrie, SM, Marsh, C, Kelly, C, Mansfield, M, McCafferty, C, Khan, K, Muller-Sedgwick, U, Strang, J, Williamson, G, Wilson, L, Young, S, Landau, S & Thomson, LDG 2022, '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', British Journal of Psychiatry. https://doi.org/10.1192/bjp.2022.77

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. / Asherson, Philip J.; Johansson, Lena; Holland, Rachel et al.
In: British Journal of Psychiatry, 03.06.2022.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Asherson, Philip J.

AU - Johansson, Lena

AU - Holland, Rachel

AU - Bedding, Megan

AU - Forrester, Andrew

AU - Giannulli, Laura

AU - Ginsberg, Ylva

AU - Howitt, Sheila

AU - Kretzschmar, Imogen

AU - Lawrie, Stephen M.

AU - Marsh, Craig

AU - Kelly, Caroline

AU - Mansfield, Megan

AU - McCafferty, Clare

AU - Khan, Khuram

AU - Muller-Sedgwick, Ulrich

AU - Strang, John

AU - Williamson, Grace

AU - Wilson, Lauren

AU - Young, Susan

AU - Landau, Sabine

AU - Thomson, Lindsay D. G.

PY - 2022/6/3

Y1 - 2022/6/3

N2 - 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.

AB - 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.

KW - Prisoners

KW - methylphenidate

KW - randomised controlled trial

KW - attention-deficit hyperactivity disorders

KW - forensic mental health services

U2 - 10.1192/bjp.2022.77

DO - 10.1192/bjp.2022.77

M3 - Article

SN - 0007-1250

JO - British Journal of Psychiatry

JF - British Journal of Psychiatry

ER -

Asherson PJ, Johansson L, Holland R, Bedding M, Forrester A, Giannulli L et al. 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. British Journal of Psychiatry. 2022 Jun 3. Epub 2022 Jun 3. doi: 10.1192/bjp.2022.77

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

Abstract

Keywords / Materials (for Non-textual outputs)

Access to Document

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Research output

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 (ADHD): CIAO-II study: commentary, Asherson et al

Cite this