Long-Term Olanzapine Treatment in Children With Autism

This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Drug: Olanzapine

Detailed Description

Autism is a serious childhood disorder that can significantly impair functioning and development. Educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. Haloperidol is the drug most commonly prescribed for symptoms of autism. However, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. The investigation of alternative drug treatments is necessary. This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children.

This study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do not respond to treatment will complete their participation in the study. Participants who respond to their assigned Phase I treatment will continue onto Phase II. All Phase II participants will receive olanzapine daily for 6 months. Self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19124
      • Drexel University College of Medicine at 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:

• Diagnosis of autism
• Parent or guardian willing to provide informed consent

Exclusion Criteria:

• Uncontrolled seizure disorder
• Medical illness other than autism affecting the whole body
• Obesity
• History of psychosis
• Impairment of voluntary movement
• History of olanzapine treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olanzapine; Participants will take open olanzapine for up to 20 additional weeks after phase 1.	Drug: Olanzapine; Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day; Other Names: Open Olanzapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Children's Psychiatric Rating Scale	Measured monthly throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Aberrant Behavior Checklist	Measured monthly throughout the study
Clinical Global Impressions	Measured monthly throughout the study
Treatment Emergent Symptoms Scale	Measured monthly throughout the study
Olanzapine Untoward Effects Checklist	Measured monthly throughout the study
Abnormal Involuntary Movement Scale	Measured monthly throughout the study
Neurological Rating Scale	Measured monthly throughout the study

Collaborators and Investigators

• Sponsor: Drexel University
• 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: September 1, 2004
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 14, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Child; Olanzapine; Drug Treatment
• 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; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: R01MH073524 (U.S. NIH Grant/Contract); DDTR B2-NDA (NIH)