Back to resultsOlanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia
Primary Purpose
Depression, Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
olanzapine
ziprasidone
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Comorbid Depression, Schizophrenia, Schizoaffective Disorder
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034801
Brief Title
Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia
Official Title
A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
This is a research study comparing the safety and efficacy of two active study medications
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Schizophrenia, Schizoaffective Disorder
Keywords
Depression, Comorbid Depression, Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
378 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
ziprasidone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Tuscaloosa
State/Province
Alabama
Country
United States
City
Little Rock
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Arkansas
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United States
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Anaheim
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California
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United States
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Chula Vista
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California
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United States
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Lafayette
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California
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United States
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Long Beach
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California
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United States
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Orange
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California
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United States
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Poway
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United States
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Rosemeade
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California
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United States
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San Diego
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California
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United States
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Denver
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Colorado
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United States
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New Britain
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Connecticut
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United States
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Winter Park
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Florida
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United States
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Augusta
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Georgia
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United States
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Prairie Village
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Kansas
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United States
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Gaithersburg
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Maryland
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United States
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Mt Pleasant
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Michigan
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United States
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St Louis
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Missouri
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United States
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Lincoln
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Nebraska
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United States
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Clementon
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New Jersey
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United States
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Buffalo
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New York
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United States
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New York
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New York
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United States
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Staten Island
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New York
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United States
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Charlotte
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North Carolina
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United States
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Philadelphia
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Pennsylvania
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United States
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Sioux Falls
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South Dakota
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United States
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Austin
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Texas
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United States
City
El Paso
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Texas
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United States
City
Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia
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