Clinical Trials Detalhe

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

General Information

Gender

ALL

Age

from 18 Years to 76 Years

Phase

PHASE3

Study Type

INTERVENTIONAL

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. (Braga, Portugal)

Clinicaltrial.gov

https://classic.clinicaltrials.gov/ct2/show/NCT00088465

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

Conditions

Schizophrenic Disorders

Schizoaffective Disorder

Eligibility

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