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

This study is currently recruiting participants.

Verified July 2012 by McGill University

Sponsor:

Information provided by (Responsible Party):

Ridha Joober, McGill University

ClinicalTrials.gov Identifier:

NCT00483106

First received: June 4, 2007

Last updated: July 10, 2012

Last verified: July 2012

History of Changes

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:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

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:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

0.25 mg/kg bid, orally for 7 consecutive days

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

No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thakur GA, Sengupta SM, Grizenko N, Choudhry Z, Joober R. Comprehensive phenotype/genotype analyses of the norepinephrine transporter gene (SLC6A2) in ADHD: relation to maternal smoking during pregnancy. PLoS One. 2012;7(11):e49616. doi: 10.1371/journal.pone.0049616. Epub 2012 Nov 20.

Thakur GA, Sengupta SM, Grizenko N, Choudhry Z, Joober R. Family-based association study of ADHD and genes increasing the risk for smoking behaviours. Arch Dis Child. 2012 Dec;97(12):1027-33. doi: 10.1136/archdischild-2012-301882. Epub 2012 Oct 29.

Thakur GA, Grizenko N, Sengupta SM, Schmitz N, Joober R. The 5-HTTLPR polymorphism of the serotonin transporter gene and short term behavioral response to methylphenidate in children with ADHD. BMC Psychiatry. 2010 Jun 22;10:50.

Ter-Stepanian M, Grizenko N, Zappitelli M, Joober R. Clinical response to methylphenidate in children diagnosed with attention-deficit hyperactivity disorder and comorbid psychiatric disorders. Can J Psychiatry. 2010 May;55(5):305-12.

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:	July 10, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University:

Attention Deficit Hyperactivity Disorder
Genetics
Pharmacogenetics

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 16, 2013

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