Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088491
First received: July 26, 2004
Last updated: June 20, 2007
Last verified: June 2007
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Purpose
This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine; evaluate the safety and tolerability of IM olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine depot; and determine the blood levels of IM olanzapine depot in patients at different points in time after an injection.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenic Disorders |
Drug: Intramuscular Olanzapine Depot Drug: Oral Olanzapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Determine comparative efficacy in patients with schizophrenia of non-inferiority of IM olanzapine depot high and low doses versus oral olanzapine based on exacerbation rates after 6 months of maintenance treatment
- Determine comparative efficacy in patients with schizophrenia of superiority of IM olanzapine depot low, med and high doses versus very low dose based on time to exacerbation of symptoms of schizophrenia
Secondary Outcome Measures:
- Demonstrate non-inferior efficacy in terms of exacerbation rates of high plus low dose IM olanzapine depot versus medium dose
- Provide information on transition of patients stabilized on oral olanzapine 10, 15 or 20 mg/day to therapeutic doses of IM olanzapine depot
- Demonstrate superiority of high dose, medium dose and low dose IM olanzapine depot compared with very low dose IM olanzapine depot in change from baseline to endpoint in PANSS total, positive, negative and general subscales
- Assess the safety and tolerability of high plus low dose IM olanzapine depot versus oral olanzapine
- Assess the safety and tolerability of medium dose IM olanzapine depot versus oral olanzapine
- Assess the safety and tolerability of each IM olanzapine depot treatment group versus very low dose IM olanzapine depot
- Compare the efficacy of high plus low dose IM olanzapine depot versus oral olanzapine during maintenance treatment on quality of life, drug attitude inventory, resource utilization and hospitalization measures
- Compare the efficacy of high, medium and low doses of IM olanzapine depot during maintenance treatment on quality of life, drug attitude inventory, resource utilization and hospitalization measures
- Characterize the pharmacokinetics of olanzapine following multiple dosing with IM olanzapine depot at each of the prescribed dosing regimens and to compare IM olanzapine depot pharmacokinetics with oral olanzapine pharmacokinetics
| Enrollment: | 1205 |
| Study Start Date: | June 2004 |
| Study Completion Date: | October 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have schizophrenia
- Patients must be clinically stable on antipsychotic medication
- Patients must be retrospectively judged by investigators, based on clinical interview and impression, to have been stable (with respect to their symptoms of schizophrenia) for at least 4 weeks entry into the study
- Patients must be an outpatient and have BPRS positive items scores of 4 or less to enter the study
- Female patients of childbearing potential must be using a medically accepted means of contraception.
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
- Patients must not require concomitant treatment with any other medication with primarily central nervous system activity, including antidepressants, mood stabilizers, and anticonvulsants.
- Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088491
Locations
| Finland | |
| 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. | |
| Pitkäniemi, Finland, 33380 | |
| Turkey | |
| 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. | |
| Ankara, Turkey | |
| 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. | |
| Istanbul, Turkey, 34787 | |
| 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. | |
| Izmir, Turkey | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00088491 History of Changes |
| Other Study ID Numbers: | 5985, F1D-MC-HGKA |
| Study First Received: | July 26, 2004 |
| Last Updated: | June 20, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013