AutismNCT00859664
Use of Pharmacogenetics in the Treatment of Children With Autistic Spectrum Disorders
An observational study of Autism and Neuroleptic Treatment, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Autism, Neuroleptic Treatment
- What is being tested?
- Genotyping of Cytochrome P450
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children over the age of 3, diagnosed with autism, treated with neuroleptics
Who may be able to join
- Age> 3 years
- Diagnosed with autism
- Treated with neuroleptics
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical center
Tsrifin, 70300
Ilan Youngster, MD, 972-8-9779133, imyoungster@yahoo.com
Ilan Youngster, MD
About this study
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.
Read more
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.
- Conditions
- Autism, Neuroleptic Treatment
- Being tested
- Genotyping of Cytochrome P450
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotyping of Cytochrome P450Other
Genotyping of Cytochrome P450
| Study group | Role | What they receive |
|---|---|---|
| Neuroleptics | Children with autistic spectrum disorder, treated with neuroleptics Receives: Other: Genotyping of Cytochrome P450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859664
- Sponsor's protocol ID
- 145/07
- Status last verified
- Mar 2009
- First submitted
- 10 Mar 2009
- Last updated
- 11 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pharmacogenetics in the Treatment of Children With Autistic Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00859664
- Acronym / sponsor ID
- 145/07
- Conditions
- Autism, Neuroleptic Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroleptics | – | Other: Genotyping of Cytochrome P450Children with autistic spectrum disorder, treated with neuroleptics |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children over the age of 3, diagnosed with autism, treated with neuroleptics
Key inclusion criteria (3 listed)
- Age> 3 years
- Diagnosed with autism
- Treated with neuroleptics
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotyping of Cytochrome P450Genotyping of Cytochrome P450 | Other | Neuroleptics |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Neuroleptic Treatment, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Youngster, MD (972-8-9779133, imyoungster@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2009.