Pharmacokinetic Characterization of Intramuscular Olanzapine Depot
2 other identifiers
interventional
N/A
8 countries
8
Brief Summary
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).
Trial Health
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8 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2004
CompletedFirst Posted
Study publicly available on registry
October 22, 2004
CompletedJuly 19, 2006
July 1, 2006
October 21, 2004
July 18, 2006
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
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
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, Rio de Janeiro, Brazil
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
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.
Prague, Czechia
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
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
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
Related Publications (3)
Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.
PMID: 24423017DERIVEDMcDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.
PMID: 20537130DERIVEDDetke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.
PMID: 20537128DERIVED