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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT00663442
Collaborator
National Institute of Mental Health (NIMH) (NIH)
48
Enrollment
1
Location
1
Arm
59
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: OROS methylphenidate
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
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
Study Start Date :
Dec 1, 1999
Actual Primary Completion Date :
Nov 1, 2004
Actual Study Completion Date :
Nov 1, 2004

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Concerta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ADHD RS [weekly]

    Secondary Outcome Measures

    1. CGI-S [weekly]

    2. VItal Signs [weekly]

    3. Sleep Questionnaire [weekly]

    4. Side Effects rating Scale [weekly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00663442
    Other Study ID Numbers:
    • K24-MHO1823
    First Posted:
    Apr 22, 2008
    Last Update Posted:
    Apr 22, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    ADHD
    side effects
    sleep
    dopamine
    pharmacogenetics
    Additional relevant MeSH terms:
    Methylphenidate

    Study Results

    No Results Posted as of Apr 22, 2008