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NCT00181935 · ClinicalTrials.gov registry record · Phase 4
Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00181935: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00181935 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00181935, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of extrapyramidal side effects.
Interventions
- DRUG risperidone (Risperdal)
- DRUG olanzapine (Zyprexa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2001-03 |
| Est. Completion | 2004-07 |
| Phase | Phase 4 |
What the finished NCT00181935 record still lists
NCT00181935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which risperidone (Risperdal) is the first listed.
NCT00181935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00181935 about?
NCT00181935 is a clinical study titled "Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder". The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these atypical neuroleptics ma...
What is the current status of trial NCT00181935?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2001-03. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00181935?
The interventions under investigation include: risperidone (Risperdal) (DRUG), olanzapine (Zyprexa) (DRUG).
Who is sponsoring clinical trial NCT00181935?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00181935's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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