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A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With ADHD Compared to Healthy Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Shalvata Mental Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01124032
First received: May 13, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with ADHD and compares it to its effect on healthy adults, in a double-blind crossover design.We hypothesize that Ritalin will result in better performance in all measures,and that the improvement will be greater in the ADHD group.


Condition Intervention
ADHD
 Drug: methylphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • TOVA score [ Time Frame: assessed twice, separated by 1-2 weeks. ] [ Designated as safety issue: No ]
  • IGT score [ Time Frame: assessed twice, separated by 1-2 weeks ] [ Designated as safety issue: No ]
  • FPGT score [ Time Frame: assessed twice, separated by 1-2 weeks ] [ Designated as safety issue: No ]
  • SWM score [ Time Frame: assessed twice, separated by 1-2- weeks ] [ Designated as safety issue: No ]
  • digit span score [ Time Frame: assessed twice, separated by 1-2- weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADHD adults Drug: methylphenidate
a capsule containing 20 mg
Experimental: healthy adults Drug: methylphenidate
a capsule containing 20 mg

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults in the age of 21-50

Exclusion Criteria:

  1. People diagnosed with a clinical disorder other than ADD/ADHD that may impair their performance in the tasks used in the study.
  2. People for whom there is a contra-indication for consuming Ritalin.
  3. Pregnant women and nursing women;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124032

Contacts
Contact: Ziv Carmel, MD 97297478570 zivca@clalit.org.il
Contact: Nirit Agay, Msc 97297478644 niritag@clalit.org.il

Locations
Israel
Shalvata Mental Health center Recruiting
Hod Hasharon, Israel
Principal Investigator: Ziv Carmel, MD            
Sub-Investigator: nirit agay, Msc            
Sponsors and Collaborators
Shalvata Mental Health Center
Technion, Israel Institute of Technology
  More Information

Publications:

Responsible Party: Ziv Carmel,MD, shalvata Mental health center
ClinicalTrials.gov Identifier: NCT01124032     History of Changes
Other Study ID Numbers: SHA 01-10
Study First Received: May 13, 2010
Last Updated: May 13, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013