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

King's College London0 sites200 target enrollmentMay 31, 2016

Overview

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31791384 protocol (added 04/12/2019)

Registry

who.int

Start Date

May 31, 2016

End Date

August 27, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

•Current participant inclusion criteria as of 22/01/2021:
•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 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
•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 of ADHD
•7\. Onset of symptoms before the age of 12 years
•Previous participant inclusion criteria:
•1\. Male, aged between 16 and 25 years

•Current participant exclusion criteria as of 22/01/2021:
•1\. Lack of capacity to give informed consent
•2\. Moderate or severe learning disability, defined as an IQ \<60
•3\. Serious risk of violence to the researcher
•4\. Current major depression, psychosis, mania or hypomania
•5\. Past history of bipolar disorder or schizophrenia (such as those with a clear history of episodic mania/hypomania or psychosis unrelated to acute drug intoxication. Excluding chronic emotional dysregulation such as irritability, frustration, anger or emotional\-mood instability)
•6\. Medical contraindications to the use of stimulants (e.g. glaucoma, hypertension, cardiovascular disease or structural heart problem)
•7\. 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 addition disorder with drug dependency)
•8\. Taking contraindicated medication (e.g. Clonidine, Courmarins, Monoamine oxibase inhibitors, Moclobemide, Rasagline) during the four weeks prior to randomisation
•9\. Receiving any ADHD medication between consent for screening and randomisation