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NCT00057408 · ClinicalTrials.gov registry record · Phase 2
A Controlled Study of Olanzapine in Children With Autism
A Phase 2 study, sponsored by FDA Office of Orphan Products Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT00057408: Completed Phase 2 study, sponsored by FDA Office of Orphan Products Development.
NCT00057408 is a Phase 2 study that has completed, run by FDA Office of Orphan Products Development. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00057408, a Phase 2 study, has completed, sponsored by FDA Office of Orphan Products Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG olanzapine (Zyprexa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2003-05 |
| Est. Completion | 2005-09 |
| Phase | Phase 2 |
What the finished NCT00057408 record still lists
NCT00057408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00057408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00057408 about?
NCT00057408 is a clinical study titled "A Controlled Study of Olanzapine in Children With Autism". 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...
What is the current status of trial NCT00057408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2003-05. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00057408?
The interventions under investigation include: Placebo (DRUG), olanzapine (Zyprexa) (DRUG).
Who is sponsoring clinical trial NCT00057408?
This trial is sponsored by FDA Office of Orphan Products Development, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00057408's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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