Long-Term Olanzapine Treatment in Children With Autism - Full Text View

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 II Phase III

MedlinePlus related topics:

Autism

ChemIDplus related topics:

Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Long-Term Olanzapine Treatment in Children With Autism

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	40
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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

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

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

Contacts


Contact: Richard P. Malone, MD	215-831-4058	rmalone@drexelmed.edu

Contact: Melissa Lech, BSN	215-831-4058	mlech@drexelmed.edu

Locations


United States, Pennsylvania
	Drexel University College of Medicine at Friends Hospital	Recruiting
	Philadelphia, Pennsylvania, United States, 19124
	Contact: Richard P. Malone, MD 215-831-4058 rmalone@drexelmed.edu
	Contact: Melissa Lech, BSN 215-831-4058 mlech@drexelmed.edu
	Principal Investigator: Richard P. Malone, MD
	Sub-Investigator: Mary A. Delaney, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Richard P. Malone, MD	Drexel University College of Medicine

More Information

Responsible Party:	Drexel University College of Medicine ( Richard P. Malone, MD )
Study ID Numbers:	R01 MH73524, DDTR B2-NDA
First Received:	September 13, 2005
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00183404
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Drug Treatment

Child

Olanzapine

Study placed in the following topic categories:

Child Development Disorders, Pervasive

Developmental Disabilities

Mental Disorders

Autistic Disorder

Mental Disorders Diagnosed in Childhood

Olanzapine

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183404