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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Shalvata Mental Health Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124032
First Posted: May 14, 2010
Last Update Posted: May 14, 2010
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.
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
Shalvata Mental Health Center
  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 (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • TOVA score [ Time Frame: assessed twice, separated by 1-2 weeks. ]
  • IGT score [ Time Frame: assessed twice, separated by 1-2 weeks ]
  • FPGT score [ Time Frame: assessed twice, separated by 1-2 weeks ]
  • SWM score [ Time Frame: assessed twice, separated by 1-2- weeks ]
  • digit span score [ Time Frame: assessed twice, separated by 1-2- weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: May 13, 2010
First Posted: May 14, 2010
Last Update Posted: May 14, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
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