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

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by:
University of Illinois at Chicago Identifier:
First received: April 18, 2008
Last updated: April 21, 2008
Last verified: April 2008

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
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:

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

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


Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental retardation psychoses seizure disorder
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00663442

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)
Principal Investigator: Mark A Stein, Ph.D. Univesity of Illinois at Chicago
  More Information

Responsible Party: Mark A. Stein Ph.D. 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 at Chicago:
side effects

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015