Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00088049

Purpose

The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Olanzapine Drug: Aripiprazole	Phase IV

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 Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To determine the long-term effectiveness and tolerability as measured by time to all-cause treatment discontinuation of olanzapine and aripiprazole relative to each other in patients with schizophrenia during 28 weeks of double-blind therapy

Secondary Outcome Measures:

To assess olanzapine versus aripiprazole in the following:
improvement in psychopathology of schizophrenia as measured by PANSS change
change in CGI-S and PGI-I scores
level of activation as measured by PANSS change
depressive symptoms as measured by MADRS score
response rates
time to failure to maintain response
quality of life as measured by the SWN-S and SF-36
cognitive functioning as measured by the MOS
sexual functioning as measured by the GISF
health resource utilization and resource utilization costs
hospitalization time
treatment emergent adverse events
EPS as measured by the Simpson-Angus, Barnes, and AIMS
laboratory values
vital signs

Estimated Enrollment:	560
Study Start Date:	October 2003
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female inpatient or outpatients, ages 18-65

Exclusion Criteria:

Participation in a clinical trial of another drug including olanzapine or aripiprazole within 30 days prior to study entry (visit 1).
Treatment with clozapine within the past 12 months.
Have known uncorrected narrow-angle glaucoma.
Have a diagnosis of Parkinson's disease, dementia or related disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088049

Show 24 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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided by Eli Lilly and Company

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

Liu-Seifert H, Ascher-Svanum H, Osuntokun O, Jen KY, Gomez JC. Change in level of productivity in the treatment of schizophrenia with olanzapine or other antipsychotics. BMC Psychiatry. 2011 May 17;11:87.

Kane JM, Osuntokun O, Kryzhanovskaya LA, Xu W, Stauffer VL, Watson SB, Breier A. A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia. J Clin Psychiatry. 2009 Apr;70(4):572-81. Epub 2009 Mar 24.

ClinicalTrials.gov Identifier:	NCT00088049 History of Changes
Other Study ID Numbers:	8047, F1D-MC-HGLB
Study First Received:	July 19, 2004
Last Updated:	July 16, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Aripiprazole
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 February 09, 2012