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

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ClinicalTrials.gov Identifier: NCT01040702
Recruitment Status : Completed
First Posted : December 30, 2009
Last Update Posted : December 30, 2009
Sponsor:
Information provided by:
Shalvata Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: methylphenidate Dietary Supplement: sweetener pill Phase 1

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  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Methylphenidate on Decision-making Ability of ADHD Adults
Study Start Date : January 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Ritalin
Placebo Comparator: ADHD-placebo
adults with ADHD diagnosis who received placebo
Dietary Supplement: sweetener pill
a capsule containing a sweetener pill
Other Name: 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 Name: Ritalin
Placebo Comparator: non-ADHD-placebo
healthy adults who received placebo
Dietary Supplement: sweetener pill
a capsule containing a sweetener pill
Other Name: sukrazit



Primary Outcome Measures :
  1. score in decision-making task 1 [ Time Frame: by the end of the task ]

Secondary Outcome Measures :
  1. working memory task score [ Time Frame: by the end of the task ]


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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:

  • 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.

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): NCT01040702


Locations
Israel
cognitive laboratory,Shalvata MHC
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Ziv Carmel, MD MD

Responsible Party: Ziv Carmel,MD, Shalvata MHC
ClinicalTrials.gov Identifier: NCT01040702     History of Changes
Other Study ID Numbers: SH-40107
First Posted: December 30, 2009    Key Record Dates
Last Update Posted: December 30, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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