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NCT00191399 · ClinicalTrials.gov registry record · Phase 4
Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT00191399: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00191399 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00191399, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).
Interventions
- DRUG Olanzapine
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-05 |
| Est. Completion | 2006-03 |
| Phase | Phase 4 |
What the finished NCT00191399 record still lists
NCT00191399 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Olanzapine is the first listed.
NCT00191399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00191399 about?
NCT00191399 is a clinical study titled "Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response". The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).
What is the current status of trial NCT00191399?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2004-05. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00191399?
The interventions under investigation include: Olanzapine (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00191399?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00191399's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 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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