Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by McGill University
Sponsor:
Information provided by (Responsible Party):
Ridha Joober, McGill University
ClinicalTrials.gov Identifier:
NCT00483106
First received: June 4, 2007
Last updated: January 7, 2014
Last verified: January 2014
  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
Attention Deficit Hyperactivity Disorder
Drug: Ritalin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Conners' Global Index - Parent Version (CGI-P) [ Time Frame: Once weekly during the medication trial ] [ Designated as safety issue: No ]
  • Conner's Global Index - Teacher Version (CGI-T) [ 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: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ritalin Drug: Ritalin
0.25 mg/kg bid, orally for 7 consecutive days
Placebo Comparator: Placebo 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
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 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

No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ridha Joober, Md, PhD., McGill University
ClinicalTrials.gov Identifier: NCT00483106     History of Changes
Other Study ID Numbers: 99-22
Study First Received: June 4, 2007
Last Updated: January 7, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:
Attention Deficit Hyperactivity Disorder
Genetics
Pharmacogenetics

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014