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

NCT01962181 | Unknown

• 1 other identifier: RE0379-HMO-STILL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

"Attention Deficit Hyperactivity Disorder"

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.

  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.

  2 years

Study Arms (2)

Ritalin

ACTIVE COMPARATOR

Ritalin treatment at different doses

Drug: Ritalin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ritalin DRUG

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

Ritalin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel, 91000, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Renana Eitan, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renana Eitan, MD

CONTACT

renanaeitan@gmail.com

Shahar Arzy, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2013
• First Posted: October 14, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 14, 2013

Record last verified: 2013-09

Locations

IL (1)