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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034801
First received: May 2, 2002
Last updated: July 18, 2006
Last verified: July 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
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, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00034801     History of Changes
Other Study ID Numbers: 5529, F1D-US-HGJU
Study First Received: May 2, 2002
Last Updated: July 18, 2006
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:
Depression
Depressive Disorder
Psychotic Disorders
Schizophrenia
Behavioral Symptoms
Mental Disorders
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014