Use of Pharmacogenetics in the Treatment of Children With Autistic Spectrum Disorders

Autism Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00859664
• Other study ID #: 145/07
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2009
• Last updated: March 10, 2009
• Start date: March 2009
• Est. completion date: July 2011

Study information

• Verified date: March 2009
• Source: Assaf-Harofeh Medical Center
• Contact: Ilan Youngster, MD
• Phone: 972-8-9779133
• Email: imyoungster[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age> 3 years

• Diagnosed with autism

• Treated with neuroleptics

Exclusion Criteria:

• Patients with known allergy to second generation neuroleptics.

• Patients with moderate to severe renal insufficiency

• Patients with liver disease

• Patients with active cardiac disease

• Patients with hypertension not responsive to anti-hypertensive therapy

• Patients with substance abuse

• Suicidal patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autism
• Neuroleptic Treatment

Intervention

Other:
• Genotyping of Cytochrome P450
Genotyping of Cytochrome P450

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No