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Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory

NCT ID: NCT00530257

Last Updated: 2011-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-06-30

Brief Summary

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This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).

Detailed Description

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This study investigates the effect of Osmotic-Release Oral System (OROS)-methylphenidate, a long-acting stimulant, on multiple dimensions of attention and on working memory. Specifically, we will investigate the following two hypotheses: (1) OROS-methylphenidate will result in improved performance on measures assessing multiple domains of attention, including sustained attention, attentional control, selective attention, and divided attention, and (2) OROS-methylphenidate will result in improved performance on measures of working memory. In addition we will use the study to collect pilot data on whether the magnitude of the effect of OROS-methylphenidate varies across the different components of attention and working memory and whether improvement across any of these measures is helpful in predicting parent or teacher ratings of improvement.

Conditions

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Attention Deficit Hyperactivity Disorder

Keywords

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Attention Deficit Hyperactivity Disorder Methylphenidate Attention Working Memory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo (sugar pill);Subjects will be equally randomized and will receive one week of treatment with placebo and compared to subjects who were randomized to receive one week of OROS-methylphenidate.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (sugar pill)

OROS-methylphenidate

Subjects will be equally randomized and will receive one week of treatment with the optimal dose of OROS methylphenidate compared with subjects randomized to receive one week of placebo.

Group Type ACTIVE_COMPARATOR

OROS-methylphenidate

Intervention Type DRUG

18 mg to 54 mg once a day for 1 week

Interventions

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Placebo

Placebo (sugar pill)

Intervention Type DRUG

OROS-methylphenidate

18 mg to 54 mg once a day for 1 week

Intervention Type DRUG

Other Intervention Names

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Concerta Osmotic-Release Oral System -methylphenidate

Eligibility Criteria

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Inclusion Criteria

* Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type
* Parent and Teacher Ratings \>85 percentile on inattention and/or hyperactivity/impulsivity scales
* Estimated Intelligence Quotient (IQ) \> 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test

Exclusion Criteria

* Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization, psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing of the gastrointestinal tract, or epilepsy
* Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation
* Use within 14-days of a monoamine oxidase inhibitor
* History of side effects on any methylphenidate preparation that required stopping the medication
* Inability to swallow a capsule or tablet
* Chronic treatment with coumarin, clonidine, or tricyclic antidepressants
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan J Blum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2004-3-3588

Identifier Type: -

Identifier Source: org_study_id