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

Lilly

Status and phase

Completed

Phase 3

Conditions

Schizophrenic Disorders

Treatments

Drug: Oral Olanzapine

Drug: Intramuscular Olanzapine Depot

Study type

Interventional

Funder types

Industry

Identifiers

NCT00088491

F1D-MC-HGKA

5985

Details and patient eligibility

About

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.

Enrollment

1,205 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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