Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00088491

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	5985, F1D-MC-HGKA
Study First Received:	July 26, 2004
Last Updated:	June 20, 2007
ClinicalTrials.gov Identifier:	NCT00088491 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Schizophrenia
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009