CIAO project
Research type
Research Study
Full title
Open label study of Concerta XL in adult offenders with ADHD
IRAS ID
94625
Contact name
Philip Asherson
Sponsor organisation
King's College London
Eudract number
2012-000517-37
ISRCTN Number
N/A
Research summary
This is a 12-week open label study of an extended release formulation of methylphenidate (Concerta XL) on aggression and engagement in educational activities in young male prisoners with attention deficit hyperactivity disorder (ADHD). Methylphenidate is the first line treatment recommended by NICE for adults with ADHD. Participants will be 100 male prisoners aged between 18 and 30 years who provide fully informed consent and meet diagnostic criteria for ADHD. Following baseline measures treatment with Concerta XL will be initiated. The dose of Concerta will be titrated upwards over 4-weeks to maximise the treatment effects on the core symptoms of ADHD and emotional dysregulation, prior to treatment with a stable dose for a further 8-weeks. Following the 12 week trial, participants will be offered treatment as usual with Concerta and invited to take part in a further follow-up study with assessments after 3 and 6 months. The trial will take place at HMPYOI Isis, which is in the Belmarsh prison cluster. This is a relatively new prison which opened in 2010 and holds sentenced young male adults and category C offenders. The prison has a strong rehabilitation and resettlement emphasis and all prisoners are offered a full time occupation. This study represents a unique opportunity to evaluate rates of ADHD among young prisoners and investigate the effectiveness of a first line treatment on ADHD symptoms and emotional dysregulation in this population; and the impact of such treatment on two commonly associated behavioural problems frequently seen in the prison setting.
REC name
London - South East Research Ethics Committee
REC reference
12/LO/0787
Date of REC Opinion
21 Sep 2012
REC opinion
Further Information Favourable Opinion