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

This study has been completed.
Sponsor:
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01040702
First received: December 29, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: methylphenidate
Dietary Supplement: sweetener pill
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Methylphenidate on Decision-making Ability of ADHD Adults

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • score in decision-making task 1 [ Time Frame: by the end of the task ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • working memory task score [ Time Frame: by the end of the task ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040702

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

No publications provided

Responsible Party: Ziv Carmel,MD, Shalvata MHC
ClinicalTrials.gov Identifier: NCT01040702     History of Changes
Other Study ID Numbers: SH-40107
Study First Received: December 29, 2009
Last Updated: December 29, 2009
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 July 20, 2014