At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 524 enrolled

Drug / intervention

olanzapine +1 moredrug

Likely dose

olanzapine 10 milligramsfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00320489

NCT00320489Phase 3Completed

Compare CT.gov

A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

Eli Lilly and Company·interventional·Posted May 3, 2006·Updated Jan 23, 2012

In Brief

A Phase 3 clinical trial evaluating olanzapine and olanzapine pamoate depot for Schizophrenia. Completed, enrolled 524 participants across 49 sites in 12 countries.

Detailed Summary

To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSchizophrenia

CountriesArgentina, Brazil, Canada, France, Greece, Portugal, Puerto Rico, Romania, Slovakia, Spain, Taiwan, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2006

First PostedMay 2006

Primary CompletionSep 2009

TodayJul 2026

First PostedMay 3, 2006

Enrollment StartApr 1, 2006

Primary CompletionSep 1, 2009

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 20.2 years ago

Interventions

olanzapinedrug

10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.

olanzapine pamoate depotdrug

405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.