A Controlled Study of Olanzapine in Children With Autism

Phase 2

Completed

• Conditions: Autistic Disorder
• Interventions: Drug: olanzapine (Zyprexa); Drug: Placebo

• Registration Number: NCT00057408
• Lead Sponsor: FDA Office of Orphan Products Development

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-04-01
• Study First Submitted QC: 2003-04-01
• Study First Posted: 2003-04-02
• Study Start: 2003-05
• Study Completion: 2005-09
• Status Verified: 2011-09
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olanzapine (Zyprexa)	Treatment with olanzapine
2	Placebo	Matching placebo treatment

Primary Outcome Measures

Name	Time	Method
Children's Psychiatric Rating Scale	Weekly

Secondary Outcome Measures

Name	Time	Method
Aberant Behavior Checklist	Weekly
Abnormal Involuntary Movement Scale	Weekly
Clinical Global Impressions	Weekly
Olanzapine Untoward Effects Checklist	Weekly
Treatment Emergent Symptoms Scale	Weekly
Neurological Rating Scale	Weekly

Trial Locations

Locations (1)

Drexel University College of Medicine c/o Friends Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States