SNAP 25 Gene Study
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | April 20, 2009 | ||||||||||||
| Last Updated Date | September 14, 2012 | ||||||||||||
| Start Date ICMJE | July 2006 | ||||||||||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00885560 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | SNAP 25 Gene Study | ||||||||||||
| Official Title ICMJE | Do People With ADHD, Who Respond Well to Amphetamine Medication But Not to Methylphenidate, Have Allelic Variants of the SNAP 25 Gene? | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood for genetic analysis. |
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| Sampling Method | Probability Sample | ||||||||||||
| Study Population | ADHD patients from 6 years of age |
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| Condition ICMJE | Attention-Deficit/Hyperactivity Disorder | ||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||
| Enrollment ICMJE | 19 | ||||||||||||
| Completion Date | July 2010 | ||||||||||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 6 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00885560 | ||||||||||||
| Other Study ID Numbers ICMJE | H05-70410 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | University of British Columbia | ||||||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||||||
| Collaborators ICMJE | UBC Human Early Learning Partnership (HELP) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||||||
| Verification Date | September 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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