Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia

This study has been completed.

First Received: May 2, 2002 Last Updated: July 18, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00034801

Purpose

This is a research study comparing the safety and efficacy of two active study medications

Condition	Intervention	Phase
Depression Schizophrenia Schizoaffective Disorder	Drug: olanzapine Drug: ziprasidone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression Schizophrenia

Drug Information available for: Ziprasidone hydrochloride Olanzapine Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	378
Study Start Date:	September 2001
Estimated Study Completion Date:	March 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects 18-60 years of age
Female subjects of childbearing potential must be using a medically accepted means of contraception
Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
Subjects must be considered reliable

Exclusion Criteria:

Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
Female subjects who are either pregnant or nursing
Uncorrected hypothyroidism or hyperthyroidism
Narrow-angle glaucoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034801

Show 30 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Study ID Numbers:	5529, F1D-US-HGJU
Study First Received:	May 2, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00034801 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Depression
Comorbid Depression
Schizophrenia
Schizoaffective Disorder

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Schizophrenia
Serotonin Antagonists
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Disease

Depression
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Autonomic Agents
Mood Disorders
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009