Do effects of methylphenidate decline after long-term use? A double-blind, placebo-controlled cross-over study of effects of methylphenidate on cognitive functioning and real world behavior in treatment naïve children compared to effects after 9 months of treatment in clinical practice
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)10009841
- Registration Number
- NL-OMON49265
- Lead Sponsor
- Accare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
• 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.
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measures include observations of classroom behavior rated by trained<br /><br>investigators and as perceived by the teacher (e.g. hyperactivity, off-task<br /><br>behavior, disobedient behavior, and (verbal) aggression), as well as the<br /><br>performance on the neuropsychological test battery measuring spatial working<br /><br>memory, sustained attention, response inhibition, and motor and mental response<br /><br>speed. Furthermore, EEG measures during rest (i.e. theta and beta power,<br /><br>theta/beta ratio) and during a response inhibition task (P300 peak) will be<br /><br>analyzed. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Physical activity during classroom observation and everyday cognitief<br /><br>functioning as rated by the parents (BRIEF-P).</p><br>