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| Sponsor: | Children's Hospital of Philadelphia |
|---|---|
| Collaborator: |
Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by (Responsible Party): | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00530257 |
Purpose
This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Placebo Drug: OROS-methylphenidate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder |
| Enrollment: | 30 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 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.
|
Drug: Placebo
Placebo (sugar pill)
Other Name: Placebo
|
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Active Comparator: 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.
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Drug: OROS-methylphenidate
18 mg to 54 mg once a day for 1 week
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Nathan J Blum, M.D. | Children's Hospital of Philadelphia |
More Information
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00530257 History of Changes |
| Other Study ID Numbers: | 2004-3-3588 |
| Study First Received: | September 13, 2007 |
| Results First Received: | March 29, 2011 |
| Last Updated: | November 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Attention Deficit Hyperactivity Disorder Methylphenidate Attention Working Memory |
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |