A Study of Concerta XL on reducing ADHD symptoms and behavioural problems in adult offenders with ADHD

INTERVENTION: Participants will be randomised to receive 8‐weeks treatment with either OROS‐MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects and then maintained for a further 3 weeks. 200 participants will be recruited with 1:1 ratio of drug to placebo. Randomisation will be conducted by the King’s CTU with blinding of both investigators and participants. Randomisation will take place once informed and signed consent has been obtained, eligibility checks have been completed and before the treatment is started. We will use the King's Clinical Trials Unit’s Independent Randomisation Service, ensuring reliability and credibility in the randomisation process. Random block sizes will be used to control the numbers of subjects allocated to each group, stratified by site and in a 1:1 drug‐placebo ratio. Patient characteristics will not be taken into account in the randomisation process, but we expect a balanced ratio of cognitive ability, ADHD symptom severity and co‐occurring psychosocial and mental health problems across the drug treatment and placebo groups. Both active medication (Concerta XL 18 mg tablets) and matched placebo will be titrated weekly for 5 weeks and then kept at stable maintenance dose for 3 weeks. The maximum titrated dose (or matching placebo) is as follows: Week 1 = 18 mg (1 tablet); Week 2 = 36 mg (2 tablets); Week 3 = 54 mg (3 tablets); Week 4 = 72 mg (4 tablets); Week 5 = 72 mg (4 tablets); Week 6 = 72 mg (4 tablets); Week 7 = 72mg (4 tablets); Week 8 = 72mg (4 tablets). Titration of dose is conducted by the study psychiatrist. Both the trial investigators and participants are blinded. The titration protocol is followed in the same way for both active medication (IMP) and placebo. Treatment will start at an initial dose of 18 mg (1 tablet) for 1 week, and be increased weekly in 18 mg increments to a maximum of 72 mg (4 tablets) (i.e. 18 mg (1 tablet), 36 mg (2 tablets), 54 mg (3 tablets) and 72 mg (4 tablets). M CONDITION: Specialty: Mental Health, Primary sub‐specialty: Learning disorders; UKCRC code/ Disease: Mental Health/ Behavioural and emotional disorders with onset usually occurring in childhood and adolescence ; Mental and Behavioural Disorders ; Attention deficit hyperactivity disorder (ADHD) PRIMARY OUTCOME: Level of ADHD symptoms measured on the investigator rated Connors Adult ADHD rating scale measured at baseline and after 8‐weeks of treatment. SECONDARY OUTCOME: 1. Emotional dysregulation is rated by the investigator and measured on the Wender‐Reimherr Adult ADHD Diagnostic Scale at baseline and 8 weeks; 2. Number of negative Incentives and Earned Privileges (IEPs) and adjudications for antisocial behaviour and rule breaking reported in the prison records at baseline and 8 weeks; 3. Aggressive behaviour is rated by prison officer and education staff using the Modified Overt Aggression Scale at baseline and 8 weeks; 4. Number of positive incentive and earned privileges (IEPs) for positive engagement in education, occupational and rehabilitation programs recorded in the prison records at baseline and 8 weeks; 5. Attitudes towards violence are self‐rated using the Maudsley Violence Questionnaire at baseline and 8 weeks; 6. Subjective well‐being is measured using the CORE Outcome Measure (CORE_OM) at baseline and 8 weeks INCLUSION CRITERIA: 1. Male, aged between 16 and 25 years 2. English speaking 3. Able to provide informed consent (understand the information sheet and make an informed decision taking into account pros and cons of study participation) 4. Meet clinical diagnostic criteria for DSM‐5 ADHD: 5 or more current symptoms of ADHD in either the inattentive or hyperactive‐impulsive symptom domains; 6 or more symptoms of ADHD in either the inattentive or hyperactiveimpulsive symptom domains before the age of 12 years; Where it is not possible to gain sufficient clinical information to score childhood symptoms of ADHD, the operational criteria will be adapted to include evidence of several ADHD symptoms with impairment starting before the age of 12 years, and 5 or more symptoms currently with moderate to severe impairment 5. Persistent trait like (non‐episodic) course of symptoms 6. Impairments in two or more clinical or psychosocial domains and two or more settings from symptoms o