Back to resultsOlanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
olanzapine
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Disorder
Eligibility Criteria
Inclusion Criteria: Male or female subject, 18-70 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: Female subjects who are either pregnant or nursing Uncorrected hypothyroidism or hyperthyroidism Narrow-angle glaucoma Subjects who present a serious and immediate risk of endangering him or herself
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034580
Brief Title
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
Official Title
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (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 for the treatment of bipolar I disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
326 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
risperidone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subject, 18-70 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:
Female subjects who are either pregnant or nursing
Uncorrected hypothyroidism or hyperthyroidism
Narrow-angle glaucoma
Subjects who present a serious and immediate risk of endangering him or herself
Facility Information:
City
Berkley
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
San Marcos
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Middleton
State/Province
Connecticut
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Winter Park
State/Province
Florida
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Hoffman Estates
State/Province
Illinois
Country
United States
City
Natick
State/Province
Massachusetts
Country
United States
City
St Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Clementon
State/Province
New Jersey
Country
United States
City
Olean
State/Province
New York
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Madison
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Roanoke
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
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