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

Official Title: “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)”

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.

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
  • Time Frame: Baseline, 6 Weeks, 24 weeks
    Safety Issue?: No
• Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
  • Time Frame: Baseline
    Safety Issue?: No

Secondary Measures

• Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score
  • Time Frame: Baseline, 6 Weeks, 24 Weeks
    Safety Issue?: No
• Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score
  • Time Frame: Baseline, 6 Weeks, 24 Weeks
    Safety Issue?: No
• Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score
  • Time Frame: Baseline, 6 Weeks, 24 Weeks
    Safety Issue?: No
• Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)
  • Time Frame: baseline and 24 weeks
    Safety Issue?: Yes
• Increases and Decreases in Fasting Glucose Levels
  • Time Frame: over 24 weeks
    Safety Issue?: Yes
• Mean Change From Baseline to 24 Week Endpoint in Lipids
  • Time Frame: Baseline and 24 Weeks
    Safety Issue?: Yes
• Increases and Decreases in Lipid Levels
  • Time Frame: over 24 weeks
    Safety Issue?: Yes
• Mean Change From Baseline to 24 Week Endpoint in Weight
  • Time Frame: Baseline and 24 weeks
    Safety Issue?: Yes
• Weight Gain Compared to Baseline
  • Time Frame: over 24 weeks
    Safety Issue?: Yes
• Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
  • Time Frame: 24 weeks
    Safety Issue?: No
• MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment
  • Time Frame: Baseline
    Safety Issue?: No
• Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment
  • Time Frame: Baseline, 6 Weeks, 24 Weeks
    Safety Issue?: No
• Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment
  • Time Frame: Baseline, 6 Weeks, 24 Weeks
    Safety Issue?: No
• Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment
  • Time Frame: Baseline, 6 Weeks, 24 Weeks
    Safety Issue?: No
• Emotional Reactivity With the Physiological Measure of Heart Rate
  • Time Frame: 12 weeks
    Safety Issue?: No
• Emotional Reactivity With the Physiological Measure of Skin Conductance
  • Time Frame: 12 weeks
    Safety Issue?: No
• Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink
  • Time Frame: 12 weeks
    Safety Issue?: No
• Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink
  • Time Frame: 12 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259272

Study ID Number: 9675

ClinicalTrials.gov Identifier: NCT00259272

Health Authority: France: Afssaps - French Health Products Safety Agency