A Controlled Study of Olanzapine in Children With Autism

Condition(s) targeted: Autistic Disorder

Intervention: olanzapine (Zyprexa) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: FDA Office of Orphan Products Development

Official(s) and/or principal investigator(s):
Richard P Malone, MD, Principal Investigator, Affiliation: Drexel University College of Medicine

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

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.

Official title: A Controlled Study of Olanzapine in Children With Autism

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Children's Psychiatric Rating Scale

Secondary outcome:

Clinical Global Impressions

Aberant Behavior Checklist

Treatment Emergent Symptoms Scale

Olanzapine Untoward Effects Checklist

Abnormal Involuntary Movement Scale

Neurological Rating Scale

Minimum age: 3 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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).

Richard P Malone, MD, Phone: 215-831-4058, Email: rmalone@drexelmed.edu

Drexel University College of Medicine c/o Friends Hospital, Philadelphia, Pennsylvania 19124, United States; Recruiting
Richard P Malone, M.D., Phone: 215-831-4058, Email: rmalone@drexelmed.edu
Melissa Lech, BSN, Phone: 215-831-4058, Email: mlech@drexelmed.edu
Richard P Malone, MD, Principal Investigator

Starting date: May 2003
Ending date: June 2009
Last updated: July 1, 2008