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

Condition(s) targeted: Schizophrenic Disorders

Intervention: Intramuscular Olanzapine Depot (Drug); Oral Olanzapine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

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 33380, 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., 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 34787, 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., Izmir, Turkey

Lilly Clinical Trial Registry

Starting date: June 2004
Ending date: October 2006
Last updated: June 20, 2007