Attention Deficit Hyperactivity Disorder (ADHD) MedDRA version: 20.0 Level: LLT Classification code 10064104 Term: ADHD System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Concerta XL
Product Name: Concerta XL 18 mg prolonged-release tablets
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral u
Sponsors
King's College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Male, aged between 16 and 25 years (at consent for screening) -English speaking (defined as sufficient to complete study assessments) -Able to provide informed consent (understand the information sheet and make an informed decision taking into account pros and cons of study participation) -Meet clinical diagnostic criteria for DSM-5 ADHD:5 or more symptoms of ADHD in either the inattentive or hyperactive-impulsive symptom domains, 6 or more symptoms of ADHD in either the inattentive or hyperactive-impulsive 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, Persistent trait like (non-episodic) course of symptoms, Impairments in two or more clinical or psychosocial domains and two or more settings from symptoms of ADHD, Onset of symptoms before the age of 12 years Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Lack capacity to give informed consent -Moderate or severe learning disability, defined as IQ<60 -Serious risk of violence to the researcher -Current major depression, psychosis, mania or hypomania -Past history of bipolar disorder or schizophrenia (exclude those with clear history of episodic mania/hypomania or psychosis unrelated to acute drug intoxication. Do not exclude on the basis of chronic emotional dysregulation i.e. irritability, frustration, anger or emotional-mood instability) -Medical contraindications to the use of stimulants (e.g. glaucoma, hypertension, cardiovascular disease or structural heart problem) -Is taking a contraindicated medication (e.g Clonidine, Coumarins, Monoamine oxibase inhibitors, Moclobemide, Rasagline) during the 4 week prior to randomnisation. -Drug seeking behaviour or craving (defined as drug seeking behaviour that is unusually severe and likely to affect the titration protocol due to unusual and excessive demands for drugs; or where there is a current withdrawal syndrome from an addiction disorder with drug dependency) -Participant receiving any ADHD medication between consent for screening and randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is an 8-week randomised placebo controlled trial of OROS-MPH, in young adult prisoners meeting diagnostic criteria for ADHD. OROS-MPH is a long acting stimulant medication used to treat ADHD. The primary objective is to establish the efficacy of OROS-MPH in reducing ADHD symptoms (inattention and hyperactivity-impulsivity) in young male offenders aged 16-25, meeting diagnostic criteria for DSM-5 ADHD. ;Secondary Objective: To investigate the efficacy of OROS-MPH in young male offenders aged 16-25, meeting DSM-5 diagnostic criteria for ADHD, on reducing secondary outcomes that are indicators of behavioural and functional impairments used in the management of young prisoners in the UK. These include emotional dysregulation, antisocial behaviour in the prison, violent attitudes (a measure linked to aggression) and reports of behaviour from prison staff.;Primary end point(s): The primary endpoint is the level of ADHD symptoms measured on the investigator rated Connors Adult ADHD rating scale (CAARS-O). ;Timepoint(s) of evaluation of this end point: The primary endpoint is 8-weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes address important exploratory questions about the effects on comorbid symptoms and behavioural impairments that are commonly seen in offenders with ADHD. These include: emotional dysregulation (Wender-Reimherr Adult ADHD Diagnostic Scale, WRAADS) (20); the number of adjudications for antisocial behaviour and rule breaking in the previous 8-weeks; ratings of aggressive behaviour by prison staff and educational staff using the prison officer and education staff versions of the Modified Overt Aggression Scale (MOAS). Attitudes towards violence (Maudsley Violence Questionnaire, MVQ); and CORE Outcome Measure (CORE-M), a self-rated scale of subjective well-being, problems/symptoms, life functioning and risk/harm, designed to measure psychological distress before and after treatment. ;Timepoint(s) of evaluation of this end point: ADHD and ED symptoms measured at baseline and weeks 1, 2, 3, 4 and 8. Measures of aggression and engagement with educational activities are measured at baseline and then 8 week. | — |
Countries
United Kingdom
Contacts
Public ContactProf. Philip Asherson
King's College London
Outcome results
None listed