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NCT00088465 · ClinicalTrials.gov registry record · Phase 3

Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
931
Enrollment target

NCT00088465: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00088465 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 931 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00088465, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
931 participants
Enrollment target

Study Summary

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: * Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, * Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, * Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Primary Outcome

The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.

Interventions

  • DRUG Intramuscular olanzapine depot

Trial Details

FieldValue
Enrollment Target 931 participants
Start Date 2004-08
Est. Completion 2010-12
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00088465 record still lists

NCT00088465 is an interventional study that assigns participants to a tested intervention. The registered 931 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher).

The record links to 0 conditions, and to 1 intervention - of which Intramuscular olanzapine depot is the first listed.

NCT00088465 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00088465 about?

NCT00088465 is a clinical study titled "Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder". This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: * Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, ...

What is the current status of trial NCT00088465?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 931 participants. The study started on 2004-08. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00088465?

The interventions under investigation include: Intramuscular olanzapine depot (DRUG).

Who is sponsoring clinical trial NCT00088465?

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 NCT00088465's enrollment target sits among peer trials

931 338th of 2000 higher than 1,663 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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Source: ClinicalTrials.gov NCT00088465, the US trial registry maintained by the National Library of Medicine. NCT00088465 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.