Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia
NCT ID: NCT00320489
Last Updated: 2012-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
524 participants
INTERVENTIONAL
2006-04-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Olanzapine Pamoate Depot
Olanzapine pamoate depot
olanzapine pamoate depot
405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
Olanzapine
Oral olanzapine
olanzapine
10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
Interventions
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olanzapine
10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
olanzapine pamoate depot
405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
* Disease symptoms must meet a certain range as assessed by the clinician.
* Patient has experienced at least two episodes of clinical worsening of their condition. This could mean admission to a hospital or an emergency room visit. This could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
* The patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.
Exclusion Criteria
* Patients who are pregnant or nursing.
* Patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
* Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
* Patients with Parkinson's disease, psychosis related to dementia or other related disorders.
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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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Escondido, California, United States
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National City, California, United States
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Orange, California, United States
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San Diego, California, United States
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Washington D.C., District of Columbia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Cedarhurst, New York, United States
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Staten Island, New York, United States
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Canton, Ohio, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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Banfield, , Argentina
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Buenos Aires, , Argentina
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Mendoza, , Argentina
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Pelotas, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Burlington, Ontario, Canada
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Chatham, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Montreal, Quebec, Canada
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Dijon, , France
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Dole, , France
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La Seyne-sur-Mer, , France
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Limoges, , France
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Strasbourg, , France
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Toulon, , France
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Chaïdári, , Greece
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Haidari, Athens, , Greece
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Thessaloniki, , Greece
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Tripoli, , Greece
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Lisbon, , Portugal
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Cabo Rojo, , Puerto Rico
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Caguas, , Puerto Rico
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Mayagüez, , Puerto Rico
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Rio Piedras, , Puerto Rico
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Bucharest, , Romania
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Iași, , Romania
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Târgu Mureş, , Romania
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Bratislava, , Slovakia
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Alzira, , Spain
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Barcelona, , Spain
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Hua-Lian County, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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.
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.
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.
Other Identifiers
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F1D-MC-HGLQ
Identifier Type: OTHER
Identifier Source: secondary_id
6390
Identifier Type: -
Identifier Source: org_study_id
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