Status:
COMPLETED
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bipolar Disorder I or II
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (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 Episode
- and confirmed by the module D of the SCID (Semi-Structured Interview).
- Patients must be more than 18 of age at Visit 0.
Exclusion
- A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at the investigator's opinion, with the evaluation.
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00259272
Start Date
November 1 2005
End Date
May 1 2008
Last Update
June 24 2009
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Andilly, France, 95580
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bordeaux, France, 33076
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cornebarrieu, France, 31700
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Créteil, France, 94010