Methylphenidate Long-Term Study

Phase 1

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-003660-11-NL
• Lead Sponsor: Accare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Children between the ages 6 and 12, any ethnicity or cultural background
•Who have been diagnosed with ADHD as confirmed with the Parent Interview for Child Symptoms (PICS) (obtained during routine clinical assessment)
•Who are going to start methylphenidate as per clinical decision
•No use of methylphenidate for the past six months
•Have a bodyweight of at least 20 kilograms
•Deemed reliable and compliant with the protocol
•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: 60
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

•Intellectual disability (based on available IQ below 70 or the clinical opinion of the investigator, taking into account relevant psychosocial information, e.g. educational level/academic achievements; or as confirmed by the IDS-2 IQ screener obtained in each participant, see section 7.1.2)

Study & Design

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