The Effect of Methylphenidate on Decision-making Ability... | NCT01040702

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

NCT01040702

Sponsor

Shalvata Mental Health Center

Status

Completed

Last Update Posted

Dec 30, 2009Estimated

Enrollment

58Actual

Phase

Phase 1

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

methylphenidate
sweetener pill

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 29, 2009

First Submission Date that Met QC Criteria

Dec 29, 2009

First Posted Date

Dec 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2009

Last Update Posted Date

Dec 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADHD -MPH	Experimental	adults with ADHD diagnosis who receive a single dose of Methylphenidate	Drug: methylphenidate
ADHD-placebo	Placebo Comparator	adults with ADHD diagnosis who received placebo	Dietary Supplement: sweetener pill
non-ADHD-MPH	Experimental	healthy adults who received a single dose of Methylphenidate	Drug: methylphenidate
non-ADHD-placebo	Placebo Comparator	healthy adults who received placebo	Dietary Supplement: sweetener pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
methylphenidate	Drug	a single doses of 10-20 mg in each one of two visits	ADHD -MPH non-ADHD-MPH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
score in decision-making task 1		by the end of the task

Secondary Outcomes

Measure	Description	Time Frame
working memory task score		by the end of the task

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ziv Carmel, MD	MD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
cognitive laboratory,Shalvata MHC		Hod HaSharon			Israel

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008774	Methylphenidate
D013549	Sweetening Agents

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided