Randomised controlled trial of the short term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention deficit hyperactivity disorder

Phase 1

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
MedDRA version: 20.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2015-004271-78-GB

Lead Sponsor: King's College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 200

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

-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.