Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

Lilly

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Intramuscular Olanzapine Depot

Study type: Interventional

Funder types: Industry

Identifiers

NCT00088478

5984

F1D-MC-HGJZ

Details and patient eligibility

About

Key objectives of this clinical study are to:

• Determine how well intramuscular (IM) olanzapine depot works compared to placebo
• Evaluate the safety and tolerability of IM olanzapine depot compared to placebo
• Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).

Enrollment: 402 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have schizophrenia and be experiencing a psychotic episode
• Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
• Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
• Female patients must not be pregnant or breast-feeding
• Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia

Exclusion criteria

• Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
• One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
• Treatment with clozapine within 4 weeks prior to visit 1
• DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days
• Treatment with remoxipride within 6 months (180 days) prior to visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind