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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). 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.
Primary Outcome
The Clinical Global Impression - bipolar version - overall severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not ill; 2, minimally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severe
Interventions
- DRUG Olanzapine/Zyprexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-07 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT00186017 record still lists
NCT00186017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Olanzapine/Zyprexa is the first listed.
NCT00186017 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00186017's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 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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