Long-Term Olanzapine Treatment in Children With Autism

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Drexel University
ClinicalTrials.gov Identifier:
NCT00183404
First received: September 13, 2005
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Autism
Drug: Olanzapine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Olanzapine Treatment in Children With Autism

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aberrant Behavior Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
  • Clinical Global Impressions [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
  • Treatment Emergent Symptoms Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
  • Olanzapine Untoward Effects Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
  • Abnormal Involuntary Movement Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
  • Neurological Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: September 2004
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Open 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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183404

Locations
United States, Pennsylvania
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Richard P. Malone, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT00183404     History of Changes
Other Study ID Numbers: R01 MH073524, R01MH073524, DDTR B2-NDA
Study First Received: September 13, 2005
Last Updated: August 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Drexel University:
Drug Treatment
Child
Olanzapine

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014