A multicentre randomized double-blind placebo controlled discontinuation trial of methylphenidate

• Conditions: attention-deficit/hyperactivity disorder; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2014-002002-20-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-19
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Children between the ages of eight to eighteen, any ethnicity or cultural background.
•Children with their first prescription of any form of methylphenidate at least two years ago.
•Children who are for at least the last four weeks the subject has been using methylphenidate in the form of Concerta 36 mg or 54 mg.
•Children with an IQ > 70 (based on a previous IQ test or attending regular education).
•Parents (or the legal guardian) and children (= twelve years) have provided informed consent to participate in the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Excluded from participation in this study will be:
•Children who have not been using of methylphenidate for a continuous period > 2 months during the last two years.
•Children of parents who are planning to start new psychosocial or pharmacological therapies during the blinded period.
•Children and or parents who are unable to understand or comply with the protocol.
•Children who have any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified