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Home > "A" Clinical Trials Conditions > A Controlled Study of Olanzapine in Children with Autism  A Controlled Study of Olanzapine in Children with Autism
A Controlled Study of Olanzapine in Children with Autism
For Condition: Autistic Disorder
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a 6-week study which investigates the use of olanzapine to decrease symptoms in children, aged 4 to 12 years old, with autism. The study is double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers or the patients know whether or not they are receiving placebo or olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests and study medication (olanzapine or placebo), free of charge. At the end of the 6-week double-blind period, patients can receive 6 weeks of olanzapine as part of the study.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 4 Years/12 Years
Genders: Both
Protocol Entry Criteria: 1. Diagnosis of Autistic Disorder (DSM-IV Criteria). 2. Includes both males and females. 3. Aged 4 to 12 years inclusive. 4. Physically Healthy.
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
RichardMalone, Principal Investigator, Drexel University College of Medicine
Eastern Pennsylvania Psychiatric Institute *Recruiting*
Philadelphia, Pennsylvania, 19129
United States
Recruiting Richard Malone 215-842-4085
Additional Information:
Study ID Numbers: 2190;
Study Start Date: May 2003
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057408
Other Autistic Disorder Studies:
1. RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
2. Study of Fluoxetine in Adults With Autistic Disorder
3. A Controlled Study of Olanzapine in Children with Autism
4. Drug Treatment for Autism
5. Treatment of Autism in Children and Adolescents
Related Studies:
Other Autistic Disorder Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Controlled Study of Olanzapine in Children with Autism
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