The goals of this study are to: Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these levels to the amount of olanzapine in the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).

Condition	Treatment or Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Intramuscular Olanzapine Depot	Phase I Phase II

Ages Eligible for Study:  18 Years   -   76 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients must have schizophrenia or schizoaffective disorders.
• 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 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.

Australia, South Australia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Adelaide,  South Australia,  Australia
Belgium
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Kortenberg,  Belgium
Brazil, RJ
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Rio de Janeiro,  RJ,  Brazil
Croatia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Zagreb,  Croatia
Czech Republic
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Praha-8,  Czech Republic
Mexico, Tlalpan
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Mexico City,  Tlalpan,  Mexico
Slovakia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bratislava,  Slovakia
Spain
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Barcelona,  Spain

Study ID Numbers:  6106
Record last reviewed:  January 2005
Last Updated:  March 29, 2005
Record first received:  October 21, 2004
ClinicalTrials.gov Identifier:  NCT00094640
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08