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Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD)
This study is currently recruiting participants.
Verified by McGill University, July 2008
Sponsored by: McGill University
Information provided by: McGill University
ClinicalTrials.gov Identifier: NCT00483106
  Purpose

Attention deficit with hyperactivity disorder (ADHD) is a very common behavioral problem during childhood. It is estimated that up to 80% of this disorder could be related to genetic factors. The most common treatment for ADHD is psychostimulants. In this study, the researchers investigate the effect of genetic variants in increasing the risk for behaviours pertinent to ADHD or in modulating the response of these behaviours to methylphenidate. Response to methylphenidate is evaluated through a double blind placebo controlled one week study.


Condition Intervention Phase
ADHD
 Drug: Ritalin
Drug: Placebo
 Phase IV

Drug Information available for: Methylphenidate hydrochloride Methylphenidate
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Further study details as provided by McGill University:

Primary Outcome Measures:
  • CGI-P:Conners' Global Index - Parent Version [ Time Frame: Once weekly during the medication trial ] [ Designated as safety issue: No ]
  • CGI-T: Conner's Global Index - Teacher Version [ Time Frame: Once weekly during the medication trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: November 1999
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ritalin
    0.25 mg/kg bid, orally for 7 consecutive days
    Drug: Placebo
    taken orally twice a day for 7 consecutive days
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ADHD

Exclusion Criteria:

  • Psychosis
  • Tourette syndrome
  • Intelligence quotient (IQ) < 70
  • Pervasive developmental disorder (PDD)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483106

Contacts
Contact: Johanne Bellingham, RA (514) 761-6131 ext 2098 johanne.bellingham@douglas.mcgill.ca

Locations
Canada, Quebec
Douglas Mental Health University Institute Recruiting
Montreal, Quebec, Canada, H4H 1R3
Contact: Johanne Bellingham, RA     (514) 761-6131 ext 2098     johanne.bellingham@douglas.mcgill.ca    
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Ridha Joober, MD, PhD Douglas Mental Health University Institute
Principal Investigator: Natalie Grizenko, MD, FRCPC Douglas Mental Health University Institute
  More Information

Responsible Party: Douglas Mental Health University Institute ( Ridha Joober, MD, PhD )
Study ID Numbers: 99-22
Study First Received: June 4, 2007
Last Updated: July 22, 2008
ClinicalTrials.gov Identifier: NCT00483106  
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:
ADHD, Genetics, Pharmacogenetics

Study placed in the following topic categories:
Methylphenidate
Hyperkinesis

ClinicalTrials.gov processed this record on January 14, 2009



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