NCT00088465

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 931 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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

Conditions

• Schizophrenic Disorders
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Intramuscular olanzapine depot	45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.

Timeline

• Start date: 2004-08-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2004-07-27
• Last updated: 2012-01-11
• Results posted: 2012-01-11

Locations

92 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan