An observational study in Autism and Neuroleptic Treatment, sponsored by Assaf-Harofeh Medical Center. Status unknown at 1 site in Israel. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2009-03-11.
Sponsored by Assaf-Harofeh Medical Center · Observational
Children with autism are often treated with psychiatric drugs. These medications have been shown to improve their language and social function, and are important in improving their quality of life. In many cases it is difficult to determine the best drug dose, and a favorable response occurs in only 30%-70% of individuals, with many children suffering significant adverse drug reactions.
Pharmacogenetics is the study of the role of different genes on drug behavior. The cytochrome P450 is the most important enzyme, involved in the metabolism of a vast number of drugs, including psychiatric medications. The multiple variations in this gene can result in the different response observed in different patients, even when treated with similar doses of the drug.
Hypothesis(es):
Mapping the different types of cytochrome P450 gene, in children with autistic disorders will improve the rate of success of medical treatment, and prevent adverse drug reactions.
Potential Impact:
If successful, our study can help thousands of children and their families by developing a system of "tailored medicine" that is based on the specific activity of the various enzymes present in that particular patient. Better medical treatment will facilitate better daily interactions with the children and enhance their quality of life. Furthermore, recognizing children that are resistant to medication will prevent unnecessary use of drugs.
It should be noted this is the first study focusing on children receiving psychiatric medications using pharmacogenetics. Found to be effective, this method can also be applied to other groups of medications and to other patients.
Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children over the age of 3, diagnosed with autism, treated with neuroleptics
Exclusion Criteria:
Children with autistic spectrum disorder, treated with neuroleptics
Other: Genotyping of Cytochrome P450
Genotyping of Cytochrome P450
Genotyping of the polymorphic cytochrome P450 (CYP) 2D6 gene, in children with autistic spectrum disorder treated with neuroleptics, will improve treatment efficacy and prevent undesired adverse drug reactions.
Time frame: 2 years
This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Assaf-Harofeh Medical Center