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

March 10, 2009 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Assaf Harofeh Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children over the age of 3, diagnosed with autism, treated with neuroleptics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neuroleptics
Children with autistic spectrum disorder, treated with neuroleptics
Other: Genotyping of Cytochrome P450
Genotyping of Cytochrome P450

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2011

Study Completion (ANTICIPATED)

July 1, 2011

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (ESTIMATE)

March 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 145/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism

Clinical Trials on Genotyping of Cytochrome P450

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe