Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia - Full Text View

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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics:

Depression Schizophrenia

ChemIDplus related topics:

Olanzapine Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

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

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

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

Keywords provided by Eli Lilly and Company:

Depression

Comorbid Depression

Schizophrenia

Schizoaffective Disorder

Study placed in the following topic categories:

Schizophrenia

Dopamine

Depression

Mental Disorders

Olanzapine

Mood Disorders

Psychotic Disorders

Ziprasidone

Depressive Disorder

Serotonin

Schizophrenia and Disorders with Psychotic Features

Behavioral Symptoms

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

Dopamine Antagonists

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Antagonists

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008