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

NCT ID: NCT01962181

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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"Attention Deficit Hyperactivity Disorder"

Keywords

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EEG Attention Deficit / Hyperactivity Disorder (ADHD) Ritalin machine learning

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Ritalin

Ritalin treatment at different doses

Group Type ACTIVE_COMPARATOR

Ritalin

Intervention Type DRUG

Patients with ADHD and healthy subjects will be examined under Ritalin or placebo

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ritalin

Patients with ADHD and healthy subjects will be examined under Ritalin or placebo

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renana Eitan, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Center

Jerusalem, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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Renana Eitan, MD

Role: CONTACT

Email: [email protected]

Shahar Arzy, MD

Role: CONTACT

Facility Contacts

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Renana Eitan, MD

Role: primary

Other Identifiers

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RE0379-HMO-STILL

Identifier Type: -

Identifier Source: org_study_id