Clinical trial NCT00057408: A Controlled Study of Olanzapine in Children With Autism
Official title: A Controlled Study of Olanzapine in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autistic Disorder
Keywords: Autism
Pervasive Developmental Disorder
Treatment
Olanzapine
Antipsychotic
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-04-02
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Children's Psychiatric Rating Scale
timeFrame: Weekly
Secondary outcomes:
measure: Clinical Global Impressions
timeFrame: Weekly
measure: Aberant Behavior Checklist
timeFrame: Weekly
measure: Treatment Emergent Symptoms Scale
timeFrame: Weekly
measure: Olanzapine Untoward Effects Checklist
timeFrame: Weekly
measure: Abnormal Involuntary Movement Scale
timeFrame: Weekly
measure: Neurological Rating Scale
timeFrame: Weekly
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University College of Medicine c/o Friends Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Richard P Malone, MD
role: PRINCIPAL_INVESTIGATOR
References: