SNAP 25 Gene Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885560
Recruitment Status : Terminated (Collecting data for the population involved was very difficult. Over 3 years, only 19 participants were recruited.)
First Posted : April 22, 2009
Last Update Posted : September 18, 2012
UBC Human Early Learning Partnership (HELP)
Information provided by (Responsible Party):
University of British Columbia

Brief 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.

Condition or disease
Attention-Deficit/Hyperactivity Disorder

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.

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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 Start Date : July 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Whole blood for genetic analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
ADHD patients from 6 years of age

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885560

Canada, British Columbia
Provincial ADHD Program, BC Children's & Women's Health Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
UBC Human Early Learning Partnership (HELP)
Principal Investigator: Margaret D. Weiss, MD, Ph.D University of British Columbia
Study Director: Jim Kennedy, MD University of British Columbia
Study Director: Atilla Turgay, MD British Columbia Children's & Women's Hospital

Responsible Party: University of British Columbia Identifier: NCT00885560     History of Changes
Other Study ID Numbers: H05-70410
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by University of British Columbia:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors