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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00320489 |
To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: olanzapine pamoate depot Drug: olanzapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia |
Enrollment: | 514 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Olanzapine pamoate depot
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Drug: olanzapine pamoate depot
405mg, intramuscular injection, followed 4 weeks later by 150-405mg flexible dosing, intramuscular injection, every 4 weeks for 96 weeks.
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B: Active Comparator
Oral olanzapine
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Drug: olanzapine
10mg, oral tablets, once daily for 4 weeks followed by 5-20mg flexible dosing, oral tablets, once daily, for 100 weeks.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | 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) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 6390, F1D-MC-HGLQ |
Study First Received: | April 28, 2006 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00320489 |
Health Authority: | United States: Food and Drug Administration |
Schizophrenia Mental Disorders Olanzapine |
Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |