The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults

December 29, 2009 updated by: Shalvata Mental Health Center

The Effect of Methylphenidate on Decision-making Ability of ADHD Adults

The aim of the study is to assess the effect of Methylphenidate on cognitive performance and decision-making ability of ADHD adults, and to compare this effect to the effect on healthy control adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two matched groups of adults - with and without ADHD diagnosis - will perform a battery of computerized tasks assessing sustained attention,working-memory,non-verbal IQ,and decision-making ability. In each group,half of the participants will perform the tasks after receiving a capsule containing methylphenidate (MPH), and the other half will perform the tasks after receiving placebo. Task performance measures will then be compared in order to assess the effect of MPH on these domains.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

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
        • cognitive laboratory,Shalvata MHC

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:

  • pregnant or nursing women.
  • people who suffer from a psychiatric disorder other than ADHD which could account for their inattention symptoms better than ADHD.
  • people who lack judgment or are unable to communicate with the experimenters.
  • people who are incapable of performing the computerized tasks due to sensory or motor disabilities.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADHD -MPH
adults with ADHD diagnosis who receive a single dose of Methylphenidate
Drug: methylphenidate
a single doses of 10-20 mg in each one of two visits
Other Names:
  • Ritalin
Placebo Comparator: ADHD-placebo
adults with ADHD diagnosis who received placebo
Dietary supplement: sweetener pill
a capsule containing a sweetener pill
Other Names:
  • sukrazit
Experimental: non-ADHD-MPH
healthy adults who received a single dose of Methylphenidate
Drug: methylphenidate
a single doses of 10-20 mg in each one of two visits
Other Names:
  • Ritalin
Placebo Comparator: non-ADHD-placebo
healthy adults who received placebo
Dietary supplement: sweetener pill
a capsule containing a sweetener pill
Other Names:
  • sukrazit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
score in decision-making task 1
Time Frame: by the end of the task
by the end of the task

Secondary Outcome Measures

Outcome Measure
Time Frame
working memory task score
Time Frame: by the end of the task
by the end of the task

Collaborators and Investigators

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

Sponsor

Shalvata Mental Health Center

Investigators

  • Principal Investigator: Ziv Carmel, MD, MD

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

January 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 29, 2009

First Submitted That Met QC Criteria

December 29, 2009

First Posted (Estimate)

December 30, 2009

Study Record Updates

Last Update Posted (Estimate)

December 30, 2009

Last Update Submitted That Met QC Criteria

December 29, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-40107

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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