Clinical Trials Directory

Trials / Completed

CompletedNCT00259272

Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine

Phase IIIb, Multicenter, Single-Arm Open-Label Study, Supporting the Development and the Validation of the MATHYS Scale (Multidimensional Assessment of THYmic States) in a Population of Bipolar Patients Treated With Olanzapine, Either in-Label (Manic and Mixed Patients) and Off-Label (Hypomanic and Bipolar Depression)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
141 (actual)
Sponsor
Eli Lilly and Company · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGolanzapine5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.

Timeline

Start date
2005-11-01
Primary completion
2008-05-01
Completion
2008-05-01
First posted
2005-11-29
Last updated
2009-06-24
Results posted
2009-06-24

Locations

16 sites across 1 country: France

Source: ClinicalTrials.gov record NCT00259272. Inclusion in this directory is not an endorsement.