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NCT00194064 · ClinicalTrials.gov registry record · Phase 3
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT00194064: Clinical Trial Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
NCT00194064 is a Phase 3 study that was terminated before completion, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00194064, a Phase 3 study, was terminated before completion, sponsored by University Hospitals Cleveland Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.
Interventions
- DRUG Olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2002-07 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
Why NCT00194064 stopped before completion
NCT00194064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Olanzapine is the first listed.
NCT00194064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00194064 about?
NCT00194064 is a clinical study titled "Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine". Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days...
What is the current status of trial NCT00194064?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2002-07. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00194064?
The interventions under investigation include: Olanzapine (DRUG).
Who is sponsoring clinical trial NCT00194064?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00194064's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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