Identifying Characteristic Signature of Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment

Not Applicable

• Conditions: "Attention Deficit Hyperactivity Disorder"
• Interventions: Drug: Ritalin; Drug: Placebo

• Registration Number: NCT01962181
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment.

Detailed Description

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment. All subjects will undergo 1-4 EEG sessions. In each session we will use a different dose of Ritalin or placebo. A detailed neuropsychological tests will be done during the EEG recording. A powerful machine-learning techniques will be used in order to find a specific signature of ADHD and Ritalin treatment in the EEG recording.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-09-15
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-10
• Last Update Submitted: 2013-10-10
• Study First Posted: 2013-10-14
• Last Update Posted: 2013-10-14
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy subjects, aged 18-50 years.
• Subjects aged 18-50 years diagnosed with ADHD and treated with Ritalin regularly (at least once a week).

Exclusion Criteria

• Patients previously diagnosed as suffering from a brain disease except for ADHD.
• Patients after traumatic head injury.
• Patients who are unable to express their consent to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ritalin	Ritalin	Ritalin treatment at different doses
Placebo	Placebo	Two meetings, one of which will be given a placebo and the other will be given a low dose of Ritalin, randomly.

Primary Outcome Measures

Name	Time	Method
Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.	2 years	The primary outcome measure is the difference in the analysis of EEG recording (for example, resting oscillation activity and Event-related-Potentials) in Attention Deficit / Hyperactivity Disorder (ADHD) vs. healthy subjects.

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel