Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
NCT ID: NCT00088478
Last Updated: 2007-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
402 participants
INTERVENTIONAL
2004-06-30
2005-04-30
Brief Summary
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* Determine how well intramuscular (IM) olanzapine depot works compared to placebo
* Evaluate the safety and tolerability of IM olanzapine depot compared to placebo
* Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Intramuscular Olanzapine Depot
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 the study entry
* Female patients must not be pregnant or breast-feeding
* Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
Exclusion Criteria
* One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
* Treatment with clozapine within 4 weeks prior to visit 1
* DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days
* Treatment with remoxipride within 6 months (180 days) prior to visit 1
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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National City, California, United States
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Orange, California, United States
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Rosemead, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
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Lake Charles, Louisiana, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Saint Louis, Michigan, United States
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Kansas City, Missouri, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Clementon, New Jersey, United States
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Lawrence, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Beachwood, Ohio, United States
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Chagrin Falls, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Travelers Rest, South Carolina, United States
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Houston, Texas, United States
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Kirkland, Texas, United States
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San Antonio, Texas, United States
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Kirkland, Washington, United States
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Zagreb, , Croatia
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Moscow, , Russia
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Saint Petersburg, , Russia
Countries
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References
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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.
Detke HC, Zhao F, Witte MM. Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data. BMC Psychiatry. 2012 May 30;12:51. doi: 10.1186/1471-244X-12-51.
Witte MM, Case MG, Schuh KJ, Ascher-Svanum H. Effects of olanzapine long-acting injection on levels of functioning among acutely ill patients with schizophrenia. Curr Med Res Opin. 2012 Mar;28(3):315-23. doi: 10.1185/03007995.2012.657300. Epub 2012 Jan 31.
Ascher-Svanum H, Zhao F, Detke HC, Nyhuis AW, Lawson AH, Stauffer VL, Montgomery W, Witte MM, McDonnell DP. Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia. BMC Psychiatry. 2011 Sep 23;11:152. doi: 10.1186/1471-244X-11-152.
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.
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.
Lauriello J, Lambert T, Andersen S, Lin D, Taylor CC, McDonnell D. An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia. J Clin Psychiatry. 2008 May;69(5):790-9. doi: 10.4088/jcp.v69n0512.
Other Identifiers
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F1D-MC-HGJZ
Identifier Type: -
Identifier Source: secondary_id
5984
Identifier Type: -
Identifier Source: org_study_id