A Controlled Study of Olanzapine in Children With Autism

Official Title: “A Controlled Study of Olanzapine in Children With Autism”

This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are 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. In the second six weeks all of the patients receive 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.

Intervention(s) in this Clinical Trial

• Drug: olanzapine (Zyprexa)
  • Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.
• Drug: Placebo
  • Matching Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Treatment with olanzapine
• Placebo Comparator: 2
  • Matching placebo treatment

Primary Measures

• Children's Psychiatric Rating Scale
  • Time Frame: Weekly
    Safety Issue?: No

Secondary Measures

• Clinical Global Impressions
  • Time Frame: Weekly
    Safety Issue?: No
• Aberant Behavior Checklist
  • Time Frame: Weekly
    Safety Issue?: No
• Treatment Emergent Symptoms Scale
  • Time Frame: Weekly
    Safety Issue?: Yes
• Olanzapine Untoward Effects Checklist
  • Time Frame: Weekly
    Safety Issue?: Yes
• Abnormal Involuntary Movement Scale
  • Time Frame: Weekly
    Safety Issue?: Yes
• Neurological Rating Scale
  • Time Frame: Weekly
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Males and females, Aged between 3 and 12 years.
• 2. Autistic disorder - DSM-IV criteria.
• 3. A score of at least moderately impaired on the CGI-Severity item.
• 4. Clinical judgment that medication treatment for autism is indicated.

Exclusion Criteria:

• 1. Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS.
• 2. Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).
• 3. Major depressive disorder (DSM-IV).
• 4. Bipolar disorder (DSM-IV).
• 5. History of psychoactive drug in the previous 2 weeks prior to phase 1.
• 6. A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1.
• 7. Systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure disorder (seizure disorder that is not controlled by anti-epileptic medication - a child who is seizure free for a period of 6 months on a stable dose of antiepileptic drug would be considered controlled), or diabetes mellitus.
• 8. Children with a known medical cause for autistic disorder.
• 9. Abnormal fasting blood glucose or history of diabetes.
• 10. Baseline body mass index (BMI) greater than the 90th percentile for age and gender (CDC growth charts, Kuczmarski et al, 2000) (because of risk of weight gain).
• 11. Baseline QTc >450 msec. Note: Historically, patients we evaluate do not have QTc values >450.
• 12. Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: FDA Office of Orphan Products Development U.S. Fed

Overall Clinical Trial Officials and Contacts

Richard P Malone, MD Principal Investigator Drexel University College of Medicine  

Overall Contact: Richard P Malone, MD 215-831-4058 rmalone@drexelmed.edu

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00057408

Study ID Number: 2190

ClinicalTrials.gov Identifier: NCT00057408

Health Authority: United States: Food and Drug Administration