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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

• Patients must have schizophrenia

• Female patients of childbearing potential must be using a medically accepted means of contraception

• Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.

Exclusion Criteria:

• Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry

• Female patients must not be pregnant or breast-feeding

• Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder

• Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days