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

May 13, 2010 updated by: Shalvata Mental Health Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hod Hasharon, Israel
        • Shalvata Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADHD adults
Drug: methylphenidate
a capsule containing 20 mg
Experimental: healthy adults
Drug: methylphenidate
a capsule containing 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TOVA score
Time Frame: assessed twice, separated by 1-2 weeks.
assessed twice, separated by 1-2 weeks.
IGT score
Time Frame: assessed twice, separated by 1-2 weeks
assessed twice, separated by 1-2 weeks
FPGT score
Time Frame: assessed twice, separated by 1-2 weeks
assessed twice, separated by 1-2 weeks
SWM score
Time Frame: assessed twice, separated by 1-2- weeks
assessed twice, separated by 1-2- weeks
digit span score
Time Frame: assessed twice, separated by 1-2- weeks
assessed twice, separated by 1-2- weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalvata Mental Health Center

Collaborators

Technion, Israel Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

May 13, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHA 01-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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