Clinical Trial of Concerta for the treatment of ADHD in adult offenders

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2012-000517-37-GB
• Date of registration: 31/10/2012
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: Clinical Trial of Concerta for the treatment of ADHD in adult offenders
• Scientific title: A pilot study of Concerta XL in adult offenders with ADHD - CIAO Project
• Date of first enrolment: 08/11/2012
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000517-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Professor Philip Asherson
• Affiliation: King's College London

• Name: Professor Philip Asherson
• Affiliation: King's College London

Key inclusion & exclusion criteria

Inclusion criteria:
•Male
•Aged between 18 and 30 years.
• English speaking.
• Able to provide informed consent to participate (understand the protocol and make an informed decision taking into account pros and cons of study participation).
• Meet clinical diagnostic criteria for ADHD following screening questionnaires for ADHD and diagnostic interview using the DIVA interview. DSM-IV criteria, revised to take into account recommendations from NICE and proposed DSM-V criteria, will use the following criteria:
- 6 or more symptoms of ADHD in either the inattention or hyperactivity-impulsivity symptom domains as children.
- 4 or more symptoms of ADHD in either domain as adults.
- 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 some significant symptoms with impairment starting before the age of 12 years, and 6 or more symptoms currently with significant impairment currently.
-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 (following recent national and international guidelines).
- Symptoms of ADHD not secondary to another medical or mental health condition.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
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 < 65)
• Not English speaking
• Serious risk of violence to the researcher
• Pure inattentive subtype, with 2 or less symptoms of hyperactivity-impulsivity
• Pure hyperactive impulsive subtype, with 3 or less symptoms of inattention
• Current major depression, psychosis, mania, and episodic hypomania as part of bipolar II disorder
• Past history of bipolar I or schizophrenia
• Contraindications to the use of stimulants (glaucoma, hypertension, cardiovascular disease or structural heart problem).



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Attention deficit hyperactivity disorder (ADHD)
MedDRA version: 14.1 Level: LLT Classification code 10064104 Term: ADHD System Organ Class: 100000004873

Intervention(s)

Trade Name: Concerta XL

Product Name: Concerta XL
Pharmaceutical Form: Tablet
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 18-90

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 week assessment

Primary end point(s): The primary endpoint will be the number of recorded critical incidents (records of disruptive behaviour) in the prison records in the last 3-months prior to the 12-week assessment.

Main Objective: The main question is to evaluate the effectiveness of a standard treatment for ADHD on behavioural problems, that are associated with ADHD in young male prisoners. The primary question is whether there is a decrease in aggressive behaviour following treatment of ADHD in a prison setting. Aggression is one of the main problem behaviours within the prison and previous research has shown the strong link between ADHD and aggression within adult prison populations.

Secondary Objective: Secondary question relate to the effects of ADHD on the treatment of other behavioural problems within the prison, specifically on engagement with educational activities. This is an important outcome for the rehabilitation process within the prison and previous research shows that treatment of ADHD can lead to improved ability to engage with the educational process.

Related to the main questions on behavioural outcomes, we will evaluate the effects of treatment on ADHD symptoms and mood dysregulation. Previous clinical trials indicate a good response to methylphenidate on both these sets of symptoms in adults with ADHD.

Finally we will specifically test the hypothesis that the reduction in ADHD symptoms and emotional dysregulation, following treatment with methylphenidate, leads to any improvements that are seen aggression or engagement with educational activities.

Secondary Outcome(s)

Secondary end point(s): Secondary endpoints will be recorded at the 12-week assessment:
- Ratings of aggressive behaviour by prison and education staffs (Modified Overt Aggression Scale – MOAS)
- - Engagement with education activities over previous 3 months. (Number of sessions attended, number of reports of disruptive behaviour in educational sessions, behaviour in class and social activities at the prison).
Symptoms of ADHD (CAARS) and emotional dysregulation (WRAADS).

Timepoint(s) of evaluation of this end point: 12 week assessment

Secondary ID(s)

CIAOProject

Source(s) of Monetary Support

Kings College London, Forensic and Neurodevelopmental Science Department (Prof Declan Murphy)

National Institute for Health Research

Secondary Sponsor(s)

South London and Maudsley NHS Foundation Trust

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 08/11/2018
• Date Completed: 23/02/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-000517-37/results