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

Lilly

Status and phase

Completed

Phase 3

Conditions

Schizophrenic Disorders

Schizoaffective Disorder

Treatments

Drug: Intramuscular olanzapine depot

Study type

Interventional

Funder types

Industry

Identifiers

NCT00088465

F1D-MC-HGKB (Other Identifier)

5995

Details and patient eligibility

About

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

Enrollment

931 patients

Sex

All

Ages

18 to 76 years old

Volunteers

No Healthy Volunteers

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