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

Phase 1

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Dietary Supplement: sweetener pill; Drug: methylphenidate

• Registration Number: NCT01040702
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2009-08
• Status Verified: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-29
• Study First Submitted QC: 2009-12-29
• Last Update Submitted: 2009-12-29
• Study First Posted: 2009-12-30
• Last Update Posted: 2009-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADHD-placebo	sweetener pill	adults with ADHD diagnosis who received placebo
non-ADHD-placebo	sweetener pill	healthy adults who received placebo
ADHD -MPH	methylphenidate	adults with ADHD diagnosis who receive a single dose of Methylphenidate
non-ADHD-MPH	methylphenidate	healthy adults who received a single dose of Methylphenidate

Primary Outcome Measures

Name	Time	Method
score in decision-making task 1	by the end of the task

Secondary Outcome Measures

Name	Time	Method
working memory task score	by the end of the task

Trial Locations

Locations (1)

cognitive laboratory,Shalvata MHC; 🇮🇱 Hod Hasharon, Israel