a Population health research institute, st georges university, london, united Kingdom; b John howard centre, east london foundation Trust, london, united Kingdom; c south london and Maudsley nhs Trust, london, united Kingdom ARTICLE HISTORY
The Republic of The Gambia, on the west coast of Africa, is a narrow enclave into Senegal (which surrounds the nation on three sides), with a coastline on the Atlantic Ocean, enclosing the mouth of the River Gambia. The smallest country on mainland Africa, The Gambia covers 11 295 km2 and has a population of 1705 000. There are five major ethnic groups: Mandinka, Fula, Wolof, Jola and Sarahuleh. Muslims represent 95% of the population. English is the official language but a miscellany of minor languages are also spoken (Serere, Aku, Mandjago, etc.). The Gambia has a history steeped in trade, with records of Arab traders dating back to the ninth century, its river serving as an artery into the continent, reaching as far as Mauritania. Indeed, as many as 3 million slaves were sold from the region during the trans-Atlantic slave trade. The Gambia gained independence from the UK in 1965 and joined the Commonwealth of Nations.
Background Research has shown that 20–30% of prisoners meet the diagnostic criteria for attention-deficit hyperactivity disorder (ADHD). Methylphenidate reduces ADHD symptoms, but effects in prisoners 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, randomised 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 attitudes, mental health symptoms, and prison officer and educational 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.
Background It is estimated that 20–30% of prisoners meet diagnostic criteria for attention deficit hyperactivity disorder (ADHD). Methylphenidate reduces ADHD symptoms, but its effect among prisoners remains uncertain. Objectives The primary objective was to estimate the efficacy of osmotic release oral system (OROS) methylphenidate in reducing ADHD symptoms in male prisoners aged 16–25 years who met diagnostic criteria for ADHD. Secondary objectives investigated change for associated clinical and behavioural problems and the role of ADHD symptoms in mediating change in behaviour. Design A Phase IV, 8-week, parallel-arm, double-blind, randomised, placebo-controlled trial of OROS-methylphenidate, compared with placebo, in young male adult prisoners with ADHD. Participants were randomised in a 1 : 1 ratio of OROS-methylphenidate to placebo, stratified by prison. Setting Participants were recruited from Her Majesty’s Prison and Young Offender Institution Isis (London, England) and Her Majesty’s Young Offender Institution Polmont (Falkirk, Scotland). Participants The participants were 200 male prisoners with ADHD aged 16–25 years who met the diagnostic criteria for ADHD. Exclusion criteria included moderate or severe learning disability; serious risk of violence to researchers; current major depression, psychosis, mania or hypomania, or a past history of bipolar disorder or schizophrenia; and drug-seeking behaviour that was of sufficient severity to affect the titration protocol. Intervention The intervention was overencapsulated OROS-methylphenidate (18 mg) or placebo capsules. Trial medication was titrated weekly for 5 weeks against symptom reduction and adverse effects to a final dose of one to four capsules per day, followed by a stable dose for 3 weeks. Main outcome measures The primary outcome was ADHD symptoms at 8 weeks using the investigator-rated Conners’ Adult ADHD Rating Scale-Observer. There were 13 secondary outcomes, including measures of emotional dysregulation, general psychopathology, reports of behaviour by prison staff and engagement with educational activities. Results For the primary outcome, the estimated improvement between the OROS-methylphenidate and placebo arms was 0.57 points on the Conners’ Adult ADHD Rating Scale-Observer (95% confidence interval –2.41 to 3.56) at 8 weeks, with a standardised effect size of 0.06. The difference was not statistically significant and was smaller than the difference the trial was powered to detect. Responder rate, defined as a 20% reduction in the Conners’ Adult ADHD Rating Scale-Observer score, was 48.3% for the OROS-methylphenidate arm and 47.9% for the placebo arm. None of the 13 secondary outcomes that could be formally compared between the trial arms showed a significant effect and no mediators of change in behaviour were identified. Limitations Low adherence to trial medication and low medication dose might have affected the results. Conclusion OROS-methylphenidate was not found to have an effect, compared with placebo, on the primary and secondary outcomes investigated. The findings indicate that ADHD symptoms do not respond to a standard treatment for ADHD following titration to low doses in young adults in prison. The findings do not support the routine treatment with OROS-methylphenidate of young adult prisoners meeting diagnostic criteria for ADHD. Future research Investigations of adequate, maintained dosing, non-pharmacological interventions and community studies are suggested. Trial registration This trial is registered as ISRCTN16827947 and EudraCT 2015-004271-78. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health and Care Research (NIHR) partnership. Janssen-Cilag Ltd supplied OROS-MPH (Concerta-XL). This will be published in full in Efficacy and Mechanism Evaluation; Vol. 9, No. 6. See the NIHR Journals Library website for further project information.
Background: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent disorder, seen in 20-30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled trial and open trial data of methylphenidate suggest clinically significant reductions in ADHD symptoms, emotional dysregulation, disruptive behaviour and increased engagement with educational activities. Yet, routine treatment of ADHD in offenders is not yet established clinical practice. There is continued uncertainty about the clinical response to methylphenidate (MPH), a first-line treatment for ADHD, in offenders, who often present with an array of complex mental health problems that may be better explained by states of inattentive, overactive, restless and impulsive behaviours. To address this problem, we will conduct an efficacy trial to establish the short-term effects of osmotic-controlled release oral delivery system (OROS)-methylphenidate (Concerta XL), an extended release formulation of MPH, on ADHD symptoms, emotional dysregulation and behaviour.Methods: This study is a parallel-arm, randomised, placebo-controlled trial of OROS-MPH on ADHD symptoms, behaviour and functional outcomes in young male prisoners aged 16-25, meeting Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria for ADHD. Participants are randomised to 8 weeks of treatment with OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. Two hundred participants will be recruited with a 1:1 ratio of drug to placebo. The primary outcome is change in level of ADHD symptoms after 8 weeks of trial medication.
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