- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040702
The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults
December 29, 2009 updated by: Shalvata Mental Health Center
The Effect of Methylphenidate on Decision-making Ability of ADHD Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hod Hasharon, Israel
- cognitive laboratory,Shalvata MHC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADHD -MPH
adults with ADHD diagnosis who receive a single dose of Methylphenidate
|
a single doses of 10-20 mg in each one of two visits
Other Names:
|
Placebo Comparator: ADHD-placebo
adults with ADHD diagnosis who received placebo
|
a capsule containing a sweetener pill
Other Names:
|
Experimental: non-ADHD-MPH
healthy adults who received a single dose of Methylphenidate
|
a single doses of 10-20 mg in each one of two visits
Other Names:
|
Placebo Comparator: non-ADHD-placebo
healthy adults who received placebo
|
a capsule containing a sweetener pill
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
score in decision-making task 1
Time Frame: by the end of the task
|
by the end of the task
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
working memory task score
Time Frame: by the end of the task
|
by the end of the task
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ziv Carmel, MD, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
December 29, 2009
First Submitted That Met QC Criteria
December 29, 2009
First Posted (Estimate)
December 30, 2009
Study Record Updates
Last Update Posted (Estimate)
December 30, 2009
Last Update Submitted That Met QC Criteria
December 29, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- SH-40107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Hyperactivity Disorder
-
Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
-
Cingulate TherapeuticsPremier Research Group plcActive, not recruitingADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Children's National Research InstituteRecruitingADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD - Combined Type | ADHD, Predominantly Hyperactive - Impulsive | Attention-Deficit Disorder in Adolescence | Attention-Deficit Hyperactivity...United States
-
Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
-
University Hospital Bispebjerg and FrederiksbergMental Health Services in the Capital Region, DenmarkRecruitingSleep Disturbance | Neurodevelopmental Disorders | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder | Attention-Deficit Hyperactivity Disorder, Unspecified Type | Attention-deficit Hyperactivity | Hyperkinetic Conduct DisorderDenmark
-
Corium, Inc.Worldwide Clinical Trials; Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
-
Corium, Inc.Premier Research Group plc; Almac; Prometrika, LLCActive, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
-
Massachusetts General HospitalShire Human Genetic Therapies, Inc.Active, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
-
Ataturk UniversityCompletedAttention-deficit/Hyperactivity DisorderTurkey
Clinical Trials on methylphenidate
-
University of ArkansasCompleted
-
Mahidol UniversityNot yet recruiting
-
Massachusetts General HospitalFood and Drug Administration (FDA); Center for Psychiatry And Behavioral Medicine...Completed
-
Florida International UniversityNational Institute of Mental Health (NIMH)CompletedAttention Deficit Disorder With HyperactivityUnited States
-
Ironshore Pharmaceuticals and Development, IncCompletedAttention Deficit Hyperactivity DisorderUnited States
-
Boston Children's HospitalNational Institute of Mental Health (NIMH)CompletedEpilepsy | Attention Deficit Disorder With HyperactivityUnited States
-
Milton S. Hershey Medical CenterChildren's Miracle NetworkTerminatedBehavioral Insomnia of Childhood | Attention Deficit Disorder With HyperactivityUnited States
-
Massachusetts General HospitalMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.CompletedAttention Deficit Hyperactivity DisorderUnited States
-
Massachusetts General HospitalMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Completed
-
Alza Corporation, DE, USACompleted