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NCT00186017 · ClinicalTrials.gov registry record · Phase 4
Short Term Rescue Study of Olanzapine
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT00186017: Completed Phase 4 study, sponsored by Stanford University.
NCT00186017 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00186017, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study. We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will assess the effect of olanzapine on Young Mania Rating Scale (YMRS), Hamilton and Montgomery-Asberg Depression Rating Scales (HDRS, and MADRS), and Hamilton Anxiety Rating Scales (HARS) in the above paradigms. We will also assess the influence of presentation severity (CGI-S) and polarity (mood elevation versus depression) on olanzapine response. Finally, we will assess safety and tolerability of olanzapine in the above paradigms. We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in outpatients, randomized double-blind flexibly dosed olanzapine added to prior treatment (including no treatment) will yield greater CGI-S improvement than placebo by the end of one week, and that such improvement will persist over one week of open continuation treatment.
Interventions
- DRUG Olanzapine/Zyprexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-07 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00186017
The ClinicalTrials.gov registry entry for NCT00186017 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Olanzapine/Zyprexa is the first listed.
NCT00186017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00186017 about?
NCT00186017 is a clinical study titled "Short Term Rescue Study of Olanzapine". We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study. We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will assess the effect of o...
What is the current status of trial NCT00186017?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2005-07. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00186017?
The interventions under investigation include: Olanzapine/Zyprexa (DRUG).
Who is sponsoring clinical trial NCT00186017?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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