SNAP 25 Gene Study

This study has been terminated.
(Collecting data for the population involved was very difficult. Over 3 years, only 19 participants were recruited.)
Sponsor:
Collaborator:
UBC Human Early Learning Partnership (HELP)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00885560
First received: April 20, 2009
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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
Attention-Deficit/Hyperactivity Disorder

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Biospecimen Retention:   Samples With DNA

Whole blood for genetic analysis.


Enrollment: 19
Study Start Date: July 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

ADHD patients from 6 years of age

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
  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: NCT00885560

Locations
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)
Investigators
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00885560     History of Changes
Other Study ID Numbers: H05-70410
Study First Received: April 20, 2009
Last Updated: September 14, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
ADHD
SNAP 25
amphetamine
methylphenidate

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
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 September 22, 2014