A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
Data Collection
Mental Disorders
+ Schizophrenia
+ Schizophrenia Spectrum and Other Psychotic Disorders
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.Key objectives of this clinical study are to: * Determine how well intramuscular (IM) olanzapine depot works compared to placebo * Evaluate the safety and tolerability of IM olanzapine depot compared to placebo * Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.402 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients must have schizophrenia and be experiencing a psychotic episode * Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent * Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry * Female patients must not be pregnant or breast-feeding * Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia Exclusion Criteria: * Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator * One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. * Treatment with clozapine within 4 weeks prior to visit 1 * DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days * Treatment with remoxipride within 6 months (180 days) prior to visit 1
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 37 locations
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 hrs, EST), or speak with your personal physician.
National City, United StatesSee the locationFor 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 hrs, EST), or speak with your personal physician.
Orange, United StatesFor 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 hrs, EST), or speak with your personal physician.
Rosemead, United StatesFor 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 hrs, EST), or speak with your personal physician.
San Diego, United States