Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
NCT ID: NCT00088465
Last Updated: 2012-01-11
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
931 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-08-31
Study Completion Date
2010-12-31
Brief Summary
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This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.
Key objectives of the study are to:
* Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
* Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
* Determine the blood levels of IM olanzapine depot in patients during long-term treatment
Key objectives of the study are to:
* Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
* Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
* Determine the blood levels of IM olanzapine depot in patients during long-term treatment
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Detailed Description
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Conditions
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Schizophrenic Disorders
Schizoaffective Disorder
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Intramuscular Olanzapine Depot
Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Group Type
EXPERIMENTAL
Intramuscular olanzapine depot
Intervention Type
DRUG
45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Interventions
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Intramuscular olanzapine depot
45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Intervention Type
DRUG
Other Intervention Names
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LY170053
Zyprexa Adhera
Eligibility Criteria
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Inclusion Criteria
* Patients must have schizophrenia
* Female patients of childbearing potential must be using a medically accepted means of contraception
* Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.
* Female patients of childbearing potential must be using a medically accepted means of contraception
* Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.
Exclusion Criteria
* Patients 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
* Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
* 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
* Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Minimum Eligible Age
18 Years
Maximum Eligible Age
76 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Diest, , Belgium
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Liège, , Belgium
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Beer Yaacov, , Israel
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Guadalajara, , Mexico
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Enschede, , Netherlands
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The Hague, , Netherlands
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Gdynia, , Poland
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Torun, , Poland
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Braga, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Mayagüez, , Puerto Rico
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Ponce, , Puerto Rico
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Rio Piedras, , Puerto Rico
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San Juan, , Puerto Rico
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Bucharest, , Romania
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Craiova, , Romania
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Iași, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Bratislava, , Slovakia
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George, , South Africa
Site Status
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Randburg, , South Africa
Site Status
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Barcelona, , Spain
Site Status
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Burgos, , Spain
Site Status
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Málaga, , Spain
Site Status
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Seville, , Spain
Site Status
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Falköping, , Sweden
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stockholm, , Sweden
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taipei, , Taiwan
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taoyuan District, , Taiwan
Site Status
Countries
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United States
Argentina
Australia
Austria
Belgium
Brazil
Croatia
Czechia
France
Germany
Hungary
Israel
Italy
Mexico
Netherlands
Poland
Portugal
Puerto Rico
Romania
Russia
Slovakia
South Africa
Spain
Sweden
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014 Nov;29(6):322-31. doi: 10.1097/YIC.0000000000000038.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F1D-MC-HGKB
Identifier Type: OTHER
Identifier Source: secondary_id
5995
Identifier Type: -
Identifier Source: org_study_id
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