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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034801
First Posted: May 3, 2002
Last Update Posted: July 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034801


  Hide Study Locations
Locations
United States, Alabama
Tuscaloosa, Alabama, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Anaheim, California, United States
Chula Vista, California, United States
Lafayette, California, United States
Long Beach, California, United States
Orange, California, United States
Poway, California, United States
Rosemeade, California, United States
San Diego, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
New Britain, Connecticut, United States
United States, Florida
Winter Park, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Kansas
Prairie Village, Kansas, United States
United States, Maryland
Gaithersburg, Maryland, United States
United States, Michigan
Mt Pleasant, Michigan, United States
United States, Missouri
St Louis, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New Jersey
Clementon, New Jersey, United States
United States, New York
Buffalo, New York, United States
New York, New York, United States
Staten Island, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Texas
Austin, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Eli Lilly and Company
  More Information

ClinicalTrials.gov Identifier: NCT00034801     History of Changes
Other Study ID Numbers: 5529
F1D-US-HGJU
First Submitted: May 2, 2002
First Posted: May 3, 2002
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
Depression
Comorbid Depression
Schizophrenia
Schizoaffective Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Schizophrenia
Psychotic Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Olanzapine
Ziprasidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents