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

Phase 4

Completed

• Conditions: attention disorder; Attention-Deficit/Hyperactivitiy Disorder; 10009841

• Registration Number: NL-OMON41851
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion 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.

Exclusion Criteria

• 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be the clinician based ADHD DSM-5 rating<br /><br>scale. </p><br>