Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00088478

Purpose

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).

Condition	Intervention	Phase
Schizophrenia	Drug: Intramuscular Olanzapine Depot Drug: Placebo	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Demonstrate superiority of IM olanzapine depot 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks dosages compared with placebo in the treatment of patients with schizophrenia

Secondary Outcome Measures:

To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-I
To determine the earliest time point at which 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot show superior clinical improvement compared with placebo
To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-S
To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in terms of change in PANSS Positive, PANSS Negative and PANSS General Psychopathology subscales
To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in change from baseline to endpoint in quality of life
To evaluate the safety and tolerability of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo
To characterize the pharmacokinetics of olanzapine following multiple dosing with IM olanzapine depot at each of the prescribed dosing regimens

Enrollment:	402
Study Start Date:	June 2004
Study Completion Date:	April 2005

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088478

Show 37 Study Locations

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

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

Publications indexed to this study:

Lauriello J, Lambert T, Andersen S, Lin D, Taylor CC, McDonnell D. An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia. J Clin Psychiatry. 2008 May;69(5):790-9.

Study ID Numbers:	5984, F1D-MC-HGJZ
Study First Received:	July 26, 2004
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00088478
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Olanzapine

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 14, 2009