A Controlled Study of Olanzapine in Children With Autism

Autistic Disorder Clinical Trial

Official title:

A Controlled Study of Olanzapine in Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057408
• Other study ID #: 2190
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2003
• Last updated: March 24, 2015
• Start date: May 2003
• Est. completion date: September 2005

Study information

• Verified date: September 2011
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Males and females, Aged between 3 and 12 years.

2. Autistic disorder - DSM-IV criteria.

3. A score of at least moderately impaired on the CGI-Severity item.

4. Clinical judgment that medication treatment for autism is indicated.

Exclusion Criteria:

1. Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS.

2. Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).

3. Major depressive disorder (DSM-IV).

4. Bipolar disorder (DSM-IV).

5. History of psychoactive drug in the previous 2 weeks prior to phase 1.

6. A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1.

7. 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.

8. Children with a known medical cause for autistic disorder.

9. Abnormal fasting blood glucose or history of diabetes.

10. 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).

11. Baseline QTc >450 msec. Note: Historically, patients we evaluate do not have QTc values >450.

12. Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Drug:
• olanzapine (Zyprexa)
Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United States	Drexel University College of Medicine c/o Friends Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Psychiatric Rating Scale		Weekly	No
Secondary	Clinical Global Impressions		Weekly	No
Secondary	Aberant Behavior Checklist		Weekly	No
Secondary	Treatment Emergent Symptoms Scale		Weekly	Yes
Secondary	Olanzapine Untoward Effects Checklist		Weekly	Yes
Secondary	Abnormal Involuntary Movement Scale		Weekly	Yes
Secondary	Neurological Rating Scale		Weekly	Yes