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NCT00485771 · ClinicalTrials.gov registry record · Phase 4

Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression

A Phase 4 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 4
Development phase
403
Enrollment target

NCT00485771: Completed Phase 4 study, sponsored by Eli Lilly and Company.

NCT00485771 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 403 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00485771, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 4
Development phase
403 participants
Enrollment target

Study Summary

The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.

Interventions

  • DRUG Lamotrigine
  • DRUG Olanzapine
  • DRUG Fluoxetine

Trial Details

FieldValue
Enrollment Target 403 participants
Start Date 2003-11
Est. Completion 2005-01
Phase Phase 4
Eli Lilly and Company

1,341 total trials

What the finished NCT00485771 record still lists

NCT00485771 is an interventional study that assigns participants to a tested intervention. The registered 403 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 (22% lower).

The record links to 0 conditions, and to 3 interventions - of which Lamotrigine is the first listed.

NCT00485771 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00485771 about?

NCT00485771 is a clinical study titled "Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression". The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.

What is the current status of trial NCT00485771?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 403 participants. The study started on 2003-11. Estimated completion is 2005-01.

What interventions are being tested in trial NCT00485771?

The interventions under investigation include: Lamotrigine (DRUG), Olanzapine (DRUG), Fluoxetine (DRUG).

Who is sponsoring clinical trial NCT00485771?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00485771's enrollment target sits among peer trials

403 210th of 2000 higher than 1,791 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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Source: ClinicalTrials.gov NCT00485771, the US trial registry maintained by the National Library of Medicine. NCT00485771 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.