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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01962181
Recruitment Status : Unknown
Verified September 2013 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
"Attention Deficit Hyperactivity Disorder" Drug: Ritalin Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Identifying Characteristic Signature of Brain Activity of Electroencephalogram Records in Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Active Comparator: Ritalin
Ritalin treatment at different doses
Drug: Ritalin
Patients with ADHD and healthy subjects will be examined under Ritalin or placebo

Placebo Comparator: Placebo
Two meetings, one of which will be given a placebo and the other will be given a low dose of Ritalin, randomly.
Drug: Placebo



Primary Outcome Measures :
  1. Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962181


Contacts
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Contact: Renana Eitan, MD renanaeitan@gmail.com
Contact: Shahar Arzy, MD

Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel, 91000
Contact: Renana Eitan, MD       renanaeitan@gmail.com   
Principal Investigator: Renana Eitan, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Renana Eitan, MD Hadassah Medical Center
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01962181    
Other Study ID Numbers: RE0379-HMO-STILL
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: September 2013
Keywords provided by Hadassah Medical Organization:
EEG Attention Deficit / Hyperactivity Disorder (ADHD) Ritalin machine learning
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents