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

Lilly

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder I or II

Treatments: Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259272

9675

F1D-FP-S057

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

A

Experimental group

Treatment:

Drug: olanzapine