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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00181935
The ClinicalTrials.gov registry entry for NCT00181935 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which risperidone (Risperdal) is the first listed.
NCT00181935 reports 0 study locations.
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.
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