Working… Menu

A Controlled Study of Olanzapine in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057408
Recruitment Status : Completed
First Posted : April 2, 2003
Last Update Posted : March 25, 2015
National Institute of Mental Health (NIMH)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: olanzapine (Zyprexa) Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Study of Olanzapine in Children With Autism
Study Start Date : May 2003
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

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 Name: Antipsychotic Drug

Placebo Comparator: 2
Matching placebo treatment
Drug: Placebo
Matching Placebo
Other Name: Placebo controlled

Primary Outcome Measures :
  1. Children's Psychiatric Rating Scale [ Time Frame: Weekly ]

Secondary Outcome Measures :
  1. Clinical Global Impressions [ Time Frame: Weekly ]
  2. Aberant Behavior Checklist [ Time Frame: Weekly ]
  3. Treatment Emergent Symptoms Scale [ Time Frame: Weekly ]
  4. Olanzapine Untoward Effects Checklist [ Time Frame: Weekly ]
  5. Abnormal Involuntary Movement Scale [ Time Frame: Weekly ]
  6. Neurological Rating Scale [ Time Frame: Weekly ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057408

Layout table for location information
United States, Pennsylvania
Drexel University College of Medicine c/o Friends Hospital
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
FDA Office of Orphan Products Development
National Institute of Mental Health (NIMH)
Layout table for investigator information
Principal Investigator: Richard P Malone, MD Drexel University College of Medicine

Layout table for additonal information
Responsible Party: Richard P. Malone, MD, Drexel University College of Medicine Identifier: NCT00057408     History of Changes
Other Study ID Numbers: 2190
First Posted: April 2, 2003    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: September 2011
Keywords provided by FDA Office of Orphan Products Development:
Pervasive Developmental Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Child Development Disorders, Pervasive
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents