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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01040702
Other study ID # SH-40107
Secondary ID
Status Completed
Phase Phase 1
First received December 29, 2009
Last updated December 29, 2009
Start date January 2008
Est. completion date December 2009

Study information

Verified date December 2009
Source Shalvata Mental Health Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Intervention

Drug:
methylphenidate
a single doses of 10-20 mg in each one of two visits
Dietary Supplement:
sweetener pill
a capsule containing a sweetener pill

Locations

Country Name City State
Israel cognitive laboratory,Shalvata MHC Hod Hasharon

Sponsors (1)

Lead Sponsor Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary score in decision-making task 1 by the end of the task No
Secondary working memory task score by the end of the task No
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