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

Sponsored by:	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

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia

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

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

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Olanzapine
Psychotic Disorders

Aripiprazole
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