Clinical trial NCT00183404: Long-Term Olanzapine Treatment in Children With Autism
Official title: Long-Term Olanzapine Treatment in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Autism
Keywords: Drug Treatment
Child
Olanzapine
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.

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 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

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