Back to resultsThe Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
methylphenidate
sweetener pill
Sponsored by
About this trial
This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder
Eligibility 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.
Sites / Locations
- cognitive laboratory,Shalvata MHC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
ADHD -MPH
ADHD-placebo
non-ADHD-MPH
non-ADHD-placebo
Arm Description
adults with ADHD diagnosis who receive a single dose of Methylphenidate
adults with ADHD diagnosis who received placebo
healthy adults who received a single dose of Methylphenidate
healthy adults who received placebo
Outcomes
Primary Outcome Measures
score in decision-making task 1
Secondary Outcome Measures
working memory task score
Full Information
NCT ID
NCT01040702
First Posted
December 29, 2009
Last Updated
December 29, 2009
Sponsor
Shalvata Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT01040702
Brief Title
The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults
Official Title
The Effect of Methylphenidate on Decision-making Ability of ADHD Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shalvata Mental Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADHD -MPH
Arm Type
Experimental
Arm Description
adults with ADHD diagnosis who receive a single dose of Methylphenidate
Arm Title
ADHD-placebo
Arm Type
Placebo Comparator
Arm Description
adults with ADHD diagnosis who received placebo
Arm Title
non-ADHD-MPH
Arm Type
Experimental
Arm Description
healthy adults who received a single dose of Methylphenidate
Arm Title
non-ADHD-placebo
Arm Type
Placebo Comparator
Arm Description
healthy adults who received placebo
Intervention Type
Drug
Intervention Name(s)
methylphenidate
Other Intervention Name(s)
Ritalin
Intervention Description
a single doses of 10-20 mg in each one of two visits
Intervention Type
Dietary Supplement
Intervention Name(s)
sweetener pill
Other Intervention Name(s)
sukrazit
Intervention Description
a capsule containing a sweetener pill
Primary Outcome Measure Information:
Title
score in decision-making task 1
Time Frame
by the end of the task
Secondary Outcome Measure Information:
Title
working memory task score
Time Frame
by the end of the task
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziv Carmel, MD
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
cognitive laboratory,Shalvata MHC
City
Hod Hasharon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults
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