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.

Study Overview

• Status: Completed
• Conditions: Autistic Disorder
• Intervention / Treatment: Drug: Placebo; Drug: olanzapine (Zyprexa)

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19124
      • Drexel University College of Medicine c/o Friends Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Treatment with olanzapine	Drug: olanzapine (Zyprexa); Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.; Other Names: Antipsychotic Drug
Placebo Comparator: 2; Matching placebo treatment	Drug: Placebo; Matching Placebo; Other Names: Placebo controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Children's Psychiatric Rating Scale	Weekly

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: FDA Office of Orphan Products Development
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Richard P Malone, MD, Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Study Completion: September 1, 2005

Study Registration Dates

• First Submitted: April 1, 2003
• First Submitted That Met QC Criteria: April 1, 2003
• First Posted (Estimate): April 2, 2003

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Treatment; Autism; Pervasive Developmental Disorder; Antipsychotic; Olanzapine
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine; Antipsychotic Agents
• Other Study ID Numbers: 2190