A Controlled Study of Olanzapine in Children With Autism | NCT00057408

Studies
A Controlled Study of Olanzapine in Children With Autism

NCT00057408

Sponsor

FDA Office of Orphan Products Development

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

78Estimated

Phase

Phase 2

Conditions

Autistic Disorder

Interventions

olanzapine (Zyprexa)
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Apr 1, 2003

First Submission Date that Met QC Criteria

Apr 1, 2003

First Posted Date

Apr 2, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Treatment with olanzapine	Drug: olanzapine (Zyprexa)
2	Placebo Comparator	Matching placebo treatment	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olanzapine (Zyprexa)	Drug	Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.	1

Measure	Description	Time Frame
Children's Psychiatric Rating Scale		Weekly

Measure	Description	Time Frame
Clinical Global Impressions		Weekly
Aberant Behavior Checklist		Weekly
Treatment Emergent Symptoms Scale

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Richard P Malone, MD	Drexel University College of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Drexel University College of Medicine c/o Friends Hospital		Philadelphia	Pennsylvania	19124	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37811711	Derived	Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

ID	Term
D001321	Autistic Disorder
D002659	Child Development Disorders, Pervasive

ID	Term
D000067877	Autism Spectrum Disorder
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D000077152	Olanzapine
D014150	Antipsychotic Agents

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring