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Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663442
First Posted: April 22, 2008
Last Update Posted: April 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Illinois at Chicago
  Purpose

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
ADHD Drug: OROS methylphenidate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Response Pharmacogenetic Study of ADHD

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • ADHD RS [ Time Frame: weekly ]

Secondary Outcome Measures:
  • CGI-S [ Time Frame: weekly ]
  • VItal Signs [ Time Frame: weekly ]
  • Sleep Questionnaire [ Time Frame: weekly ]
  • Side Effects rating Scale [ Time Frame: weekly ]

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
Experimental: 1
OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)
Drug: OROS methylphenidate
18, 36, 54 mg
Other Name: Concerta

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6-17 DSM IV criteria for ADHD Parents willing to complete measures

Exclusion Criteria:

  • Mental retardation psychoses seizure disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663442


Locations
United States, Illinois
HALP Clinic, University of Illinois at CHicago
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Mark A Stein, Ph.D. Univesity of Illinois at Chicago
  More Information

Publications:
Responsible Party: Mark A. Stein Ph.D.
ClinicalTrials.gov Identifier: NCT00663442     History of Changes
Other Study ID Numbers: K24-MHO1823
First Submitted: April 18, 2008
First Posted: April 22, 2008
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by University of Illinois at Chicago:
ADHD
side effects
sleep
dopamine
pharmacogenetics

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents