SNAP 25 Gene Study
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention-Deficit/Hyperactivity Disorder
Phase: N/A
Status: Terminated
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Margaret D. Weiss, MD, Ph.D, Principal Investigator, Affiliation: University of British Columbia
Jim Kennedy, MD, Study Director, Affiliation: University of British Columbia
Atilla Turgay, MD, Study Director, Affiliation: British Columbia Children's & Women's Hospital
Summary
To enhance our capacity to correctly choose the appropriate medication for ADHD patients on
the first try based on the presence of a particular variant of a gene that could be
identified on a laboratory test. It is hypothesized that patients with Attention Deficit
Hyperactivity Disorder (ADHD) who have failed to respond to methylphenidate medication, but
do respond to amphetamines, have a higher than expected incidence the allelic variants of
the SNAP 25 gene associated with ADHD, and mutations of the dopamine system genes DRD1, 2,
4, 5 and dopamine transporter and COMTand MAOA.
Clinical Details
Official title: Do People With ADHD, Who Respond Well to Amphetamine Medication But Not to Methylphenidate, Have Allelic Variants of the SNAP 25 Gene?
Study design: Observational Model: Case-Only, Time Perspective: Cross-Sectional
Detailed description:
Previous research has demonstrated that while 75% of patients respond to any stimulant, of
those who do not 33% will respond to a stimulant of the other class. Based on previous
research correlating increased mutations in the dopamine system genes DRD1, 2, 4, 5,
dopamine transporter, COMT, and MAOA with ADHD, we will also be investigating the
relationship between mutations in these genes and patient response to MPH and amphetamines.
This study is a pilot, but it was an obvious next step in the studies that are being done
on the genetics of ADHD. The outcome of this research, whether an association is or is not
found, will be of considerable interest to researchers internationally, and will demonstrate
the value of HELP funding in promoting research that can alleviate mental illness in
children The study will make a significant contribution to appropriate intervention for
these children, and promote greater awareness that the deficits suffered by children with
attention problems is neither willful nor a matter of intelligence, but rather a syndrome
that can be explained and can be modified with appropriate medical care.
A chi-square test will be conducted to determine whether there is differential
representation of SNAP 25 among therapeutic methylphenidate responders versus
non-responders. Statistical comparison will be performed using a two-tailed test at the .05
level of significance.
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients will be male or female outpatients who are at least 6 years of age (there is
no upper age limit)
2. Patients must meet DSM-IV criteria for ADHD
3. Patients and parents/guardians must have a degree of understanding sufficient to be
able to communicate suitably with the investigator and study coordinator
4. Patients must have tolerated the drug at therapeutic doses, but have shown a true
lack of improvement in symptoms
5. Must have shown clinically significant superiority in improvement in ADHD symptoms on
amphetamine relative to MPH.
Exclusion Criteria:
1. Must not have a true allergy to methylphenidate or amphetamines
2. Must not have a history of serious adverse reactions to methylphenidate
Locations and Contacts
Provincial ADHD Program, BC Children's & Women's Health Centre, Vancouver, British Columbia, Canada
Additional Information
Starting date: July 2006
Last updated: September 14, 2012
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