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Pharmacokinetic Characterization of Intramuscular Olanzapine Depot
This study has been completed.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00094640
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Intramuscular Olanzapine Depot
Phase I

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094640

Locations
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
Sponsors and Collaborators
Eli Lilly and Company
  More Information

Study ID Numbers: 6106, F1D-EW-LOBS
Study First Received: October 21, 2004
Last Updated: July 18, 2006
ClinicalTrials.gov Identifier: NCT00094640  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Olanzapine
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009