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Sponsors and Collaborators: |
University of Illinois National Institute of Mental Health (NIMH) |
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Information provided by: | University of Illinois |
ClinicalTrials.gov Identifier: | NCT00663442 |
Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted.
Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response
Condition | Intervention | Phase |
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ADHD |
Drug: OROS methylphenidate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Dose Response Pharmacogenetic Study of ADHD |
Enrollment: | 48 |
Study Start Date: | December 1999 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)
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Drug: OROS methylphenidate
18, 36, 54 mg
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Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
HALP Clinic, University of Illinois at CHicago | |
Chicago, Illinois, United States, 60608 |
Principal Investigator: | Mark A Stein, Ph.D. | Univesity of Illinois at Chicago |
Responsible Party: | ( Mark A. Stein Ph.D. ) |
Study ID Numbers: | K24-MHO1823 |
Study First Received: | April 18, 2008 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00663442 |
Health Authority: | United States: Institutional Review Board |
ADHD side effects sleep dopamine pharmacogenetics |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Attention Deficit and Disruptive Behavior Disorders Hyperkinesis |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |