Olanzapine Disintegrating Tablets |
Zyprexa Zydis Injection |
Clinical Trial: A Controlled Study of Olanzapine in Children with Autism
This study is currently recruiting patients.
|
Purpose
This is a 6-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 4 to 12 years old. The study is double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor 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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Autistic Disorder | Drug: olanzapine (Zyprexa) | Phase II |
MedlinePlus related topics: Autism
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 78
Study start: May 2003; Expected completion: September 2005
Eligibility
Ages Eligible for Study: 4 Years - 12 Years, Genders Eligible for Study: Both
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.
Location and Contact Information
Richard P Malone, MD (215) 831-4058 richard.malone@drexel.edu
Pennsylvania
Drexel University College of Medicine c/o Friends Hospital, Philadelphia, Pennsylvania, 19124, United States; Recruiting
Cynthia A Gifford, MSN, CPNP (215) 831-4813 cag26@drexel.edu
Richard P Malone, MD, Principal Investigator
Richard P Malone, MD, Principal Investigator, Drexel University College of Medicine
More Information
Record last reviewed: March 2003
Last Updated: October 13, 2004
Record first received: April 1, 2003
ClinicalTrials.gov Identifier: NCT00057408
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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