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

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 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 With Placebo in the Treatment of Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine Olanzapine pamoate

U.S. FDA Resources

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

Additional Information:

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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Detke HC, Zhao F, Witte MM. Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data. BMC Psychiatry. 2012 May 30;12:51.

Witte MM, Case MG, Schuh KJ, Ascher-Svanum H. Effects of olanzapine long-acting injection on levels of functioning among acutely ill patients with schizophrenia. Curr Med Res Opin. 2012 Mar;28(3):315-23. Epub 2012 Jan 31.

Ascher-Svanum H, Zhao F, Detke HC, Nyhuis AW, Lawson AH, Stauffer VL, Montgomery W, Witte MM, McDonnell DP. Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia. BMC Psychiatry. 2011 Sep 23;11:152.

McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45.

Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43.

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.

ClinicalTrials.gov Identifier:	NCT00088478 History of Changes
Other Study ID Numbers:	5984, F1D-MC-HGJZ
Study First Received:	July 26, 2004
Last Updated:	June 11, 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 19, 2013