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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT00663442
First received: April 18, 2008
Last updated: April 21, 2008
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Response Pharmacogenetic Study of ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • ADHD RS [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI-S [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • VItal Signs [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • Sleep Questionnaire [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • Side Effects rating Scale [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663442

Locations
United States, Illinois
HALP Clinic, University of Illinois at CHicago
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
University of Illinois
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
Study First Received: April 18, 2008
Last Updated: April 21, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
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

ClinicalTrials.gov processed this record on May 19, 2013