A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.

Condition	Intervention	Phase
Bipolar Disorder I or II	Drug: olanzapine	Phase III

Further study details as provided by Eli Lilly and Company:

Primary Outcomes: A principal component analysis will be run on MATHYS questionnaire items at baseline to identify the number of factors that are to be extracted
Secondary Outcomes: MATHYS, HAMD 17, HAMA, YMRS scores and changes from baseline will be described at each time points and at endpoint in the overall population and by bipolar disorder group.
Expected Total Enrollment:  200

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Patients must meet DSM-IV-TR disease diagnostic criteria for Bipolar Disorder

   • currently or most recently in a Manic Episode (Single Manic Episode or Most Recent Episode Manic) or
   • currently or most recently in a Hypomanic Episode or
   • currently or most recently in a Mixed Episode or
   • currently or most recently in a Major Depressive Epidose
   • and confirmed by the module D of the SCID (Semi-Structured Interview).
2. Patients must be more than 18 of age at Visit 0.

Exclusion Criteria:

1. A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at the investigator''''s opinion, with the evaluation.
2. Patients on antidepressant or mood stabilizer therapy one week (four weeks with fluoxetine) prior to Visit 1, with the exception of mood stabilizer therapy considered in the opinion of the investigator as an efficient treatment for at least one year prior to the study.

Please refer to this study by ClinicalTrials.gov identifier  NCT00259272

There may be a multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or      1-317-615-4559 

France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Nimes,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Cornebarrieu,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Bordeaux,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, La Seyne-sur-Mer,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Toulouse,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Pin-Balma,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Lyon,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Marseille,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Creteil,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Clermont-Ferrand,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Montpellier,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, La Rochelle,  France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Poitiers,  France

Study chairs or principal investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT-5 hours, EST),  Study Director,  Eli Lilly and Company   

Study ID Numbers:  9675
Last Updated:  December 8, 2005
Record first received:  November 28, 2005
ClinicalTrials.gov Identifier:  NCT00259272
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-01-10