Clinical trial NCT00094640: Pharmacokinetic Characterization of Intramuscular Olanzapine Depot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2004-10-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: 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.
state: South Australia
city: Kortenberg
country: Belgium
facility: 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.
city: Rio De Janeiro
country: Brazil
facility: 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.
state: RJ
city: Zagreb
country: Croatia
facility: 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.
city: Praha 8
country: Czech Republic
facility: 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.
city: Mexico City
country: Mexico
facility: 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.
state: Tlalpan
city: Bratislava
country: Slovakia
facility: 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.
city: Barcelona
country: Spain
facility: 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.
Study officials:
References:
citation: 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.
citation: McDonnell 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.
citation: Detke 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.