Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine; evaluate the safety and tolerability of IM olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine depot; and determine the blood levels of IM olanzapine depot in patients at different points in time after an injection.

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

Details

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

Criteria

Inclusion Criteria:

• Patients must have schizophrenia

• Patients must be clinically stable on antipsychotic medication

• Patients must be retrospectively judged by investigators, based on clinical interview and impression, to have been stable (with respect to their symptoms of schizophrenia) for at least 4 weeks entry into the study

• Patients must be an outpatient and have BPRS positive items scores of 4 or less to enter the study

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

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

• Patients must not require concomitant treatment with any other medication with primarily central nervous system activity, including antidepressants, mood stabilizers, and anticonvulsants.

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