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

NCT ID: NCT01040702

Last Updated: 2009-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ADHD -MPH

adults with ADHD diagnosis who receive a single dose of Methylphenidate

Group Type EXPERIMENTAL

methylphenidate

Intervention Type DRUG

a single doses of 10-20 mg in each one of two visits

ADHD-placebo

adults with ADHD diagnosis who received placebo

Group Type PLACEBO_COMPARATOR

sweetener pill

Intervention Type DIETARY_SUPPLEMENT

a capsule containing a sweetener pill

non-ADHD-MPH

healthy adults who received a single dose of Methylphenidate

Group Type EXPERIMENTAL

methylphenidate

Intervention Type DRUG

a single doses of 10-20 mg in each one of two visits

non-ADHD-placebo

healthy adults who received placebo

Group Type PLACEBO_COMPARATOR

sweetener pill

Intervention Type DIETARY_SUPPLEMENT

a capsule containing a sweetener pill

Interventions

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methylphenidate

a single doses of 10-20 mg in each one of two visits

Intervention Type DRUG

sweetener pill

a capsule containing a sweetener pill

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ritalin sukrazit

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Shalvata MHC

Principal Investigators

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Ziv Carmel, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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cognitive laboratory,Shalvata MHC

Hod HaSharon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SH-40107

Identifier Type: -

Identifier Source: org_study_id