Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder - Tabular View

Tracking Information
First Received Date ^ICMJE	April 30, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE	August 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
Official Title ^ICMJE	Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed
Brief Summary	This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bipolar Disorder
Intervention ^ICMJE	Drug: olanzapine Drug: risperidone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	326
Completion Date	August 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00034580
Responsible Party
Study ID Numbers ^ICMJE	5528, F1D-US-HGJT
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP