A Controlled Study of Olanzapine in Children With Autism - Full Text View

Sponsors and Collaborators:	FDA Office of Orphan Products Development National Institute of Mental Health (NIMH)
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00057408

Purpose

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	Intervention	Phase
Autistic Disorder	Drug: olanzapine (Zyprexa) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Controlled Study of Olanzapine in Children With Autism

Resource links provided by NLM:

MedlinePlus related topics: Autism

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Primary Outcome Measures:

Children's Psychiatric Rating Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impressions [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Aberant Behavior Checklist [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Treatment Emergent Symptoms Scale [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Olanzapine Untoward Effects Checklist [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Neurological Rating Scale [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	78
Study Start Date:	May 2003
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator Matching placebo treatment	Drug: Placebo Matching Placebo

Eligibility

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

Criteria

Inclusion Criteria:

Males and females, Aged between 3 and 12 years.
Autistic disorder - DSM-IV criteria.
A score of at least moderately impaired on the CGI-Severity item.
Clinical judgment that medication treatment for autism is indicated.

Exclusion Criteria:

Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS.
Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).
Major depressive disorder (DSM-IV).
Bipolar disorder (DSM-IV).
History of psychoactive drug in the previous 2 weeks prior to phase 1.
A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1.
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.
Children with a known medical cause for autistic disorder.
Abnormal fasting blood glucose or history of diabetes.
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).
Baseline QTc >450 msec. Note: Historically, patients we evaluate do not have QTc values >450.
Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057408

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 c/o Friends Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Richard P Malone, M.D. 215-831-4058 rmalone@drexelmed.edu
Contact: Melissa Lech, BSN 215-831-4058 mlech@drexelmed.edu
Principal Investigator: Richard P Malone, MD

Sponsors and Collaborators

FDA Office of Orphan Products Development

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Richard P Malone, MD

Drexel University College of Medicine

More Information

No publications provided

Responsible Party:	Drexel University College of Medicine ( Richard P. Malone, MD )
Study ID Numbers:	2190
Study First Received:	April 1, 2003
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00057408 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Autism
Pervasive Developmental Disorder
Treatment
Olanzapine
Antipsychotic

Study placed in the following topic categories:

Developmental Disabilities
Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Serotonin
Child Development Disorders, Pervasive
Autistic Disorder
Mental Disorders
Mental Disorders Diagnosed in Childhood
Peripheral Nervous System Agents
Autism

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Child Development Disorders, Pervasive
Serotonin Agents
Autonomic Agents
Autistic Disorder
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009