Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD)
1 other identifier
interventional
885
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 1999
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedFirst Submitted
Initial submission to the registry
June 4, 2007
CompletedFirst Posted
Study publicly available on registry
June 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMarch 16, 2021
March 1, 2021
20.4 years
June 4, 2007
March 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Conners' Global Index - Parent Version (CGI-P)
10-item standardized scale evaluating ADHD symptoms; filled by parents.
Once weekly during the medication trial
Conner's Global Index - Teacher Version (CGI-T)
10-item standardized scale evaluating ADHD symptoms; filled by teachers.
Once weekly during the medication trial
Study Arms (2)
Ritalin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- ADHD
You may not qualify if:
- Psychosis
- Tourette syndrome
- Intelligence quotient (IQ) \< 70
- Pervasive developmental disorder (PDD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3, Canada
Related Publications (8)
Fageera W, Chaumette B, Fortier ME, Grizenko N, Labbe A, Sengupta SM, Joober R. Association between COMT methylation and response to treatment in children with ADHD. J Psychiatr Res. 2021 Mar;135:86-93. doi: 10.1016/j.jpsychires.2021.01.008. Epub 2021 Jan 7.
PMID: 33453563DERIVEDNaumova D, Grizenko N, Sengupta SM, Joober R. DRD4 exon 3 genotype and ADHD: Randomised pharmacodynamic investigation of treatment response to methylphenidate. World J Biol Psychiatry. 2019 Jul;20(6):486-495. doi: 10.1080/15622975.2017.1410221. Epub 2017 Dec 15.
PMID: 29182037DERIVEDFageera W, Traicu A, Sengupta SM, Fortier ME, Choudhry Z, Labbe A, Grizenko N, Joober R. Placebo response and its determinants in children with ADHD across multiple observers and settings: A randomized clinical trial. Int J Methods Psychiatr Res. 2018 Mar;27(1):e1572. doi: 10.1002/mpr.1572. Epub 2017 Jun 30.
PMID: 28664541DERIVEDGrizenko N, Cai E, Jolicoeur C, Ter-Stepanian M, Joober R. Effects of methylphenidate on acute math performance in children with attention-deficit hyperactivity disorder. Can J Psychiatry. 2013 Nov;58(11):632-9. doi: 10.1177/070674371305801109.
PMID: 24246434DERIVEDThakur 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.
PMID: 23185385DERIVEDThakur 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.
PMID: 23109089DERIVEDThakur 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. doi: 10.1186/1471-244X-10-50.
PMID: 20569447DERIVEDTer-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. doi: 10.1177/070674371005500506.
PMID: 20482957DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ridha Joober, MD, PhD
Douglas Mental Health University Institute
- PRINCIPAL INVESTIGATOR
Natalie Grizenko, MD, FRCPC
Douglas Mental Health University Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md, PhD.
Study Record Dates
First Submitted
June 4, 2007
First Posted
June 6, 2007
Study Start
November 1, 1999
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
March 16, 2021
Record last verified: 2021-03