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

Eli Lilly and Company141 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Bipolar Disorder I or II

Interventions

olanzapineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Outcomes

Primary Outcomes

Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score

A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.

Time frame: Baseline, 6 Weeks, 24 weeks

Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix

This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.

Time frame: Baseline

Secondary Outcomes

Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score

The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).

Time frame: Baseline, 6 Weeks, 24 Weeks

Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score

The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).

Time frame: Baseline, 6 Weeks, 24 Weeks

Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score

Data from ClinicalTrials.gov

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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

Bordeaux, France

Cornebarrieu, France

Créteil, France

La Rochelle, France

La Seyne-sur-Mer, France

Lyon, France

Marseille, France

Montpellier, France

Nîmes, France

...and 6 more locations

The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

Time frame: Baseline, 6 Weeks, 24 Weeks

Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)

Time frame: baseline and 24 weeks

Increases and Decreases in Fasting Glucose Levels

Time frame: over 24 weeks

Mean Change From Baseline to 24 Week Endpoint in Lipids

Baseline, change from baseline, and percent change for the following lipids are presented: Total Cholesterol (TC), High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), and Triglycerides (TG).

Time frame: Baseline and 24 Weeks

Increases and Decreases in Lipid Levels

Time frame: over 24 weeks

Mean Change From Baseline to 24 Week Endpoint in Weight

Time frame: Baseline and 24 weeks

Weight Gain Compared to Baseline

Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline

Time frame: over 24 weeks

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

MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment

A visual analogic scale consisting of 20 items. Items scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18, which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.

Time frame: Baseline

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

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

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

Emotional Reactivity With the Physiological Measure of Heart Rate

to assess emotional reactivity with the physiological measure of heart rate, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients

Time frame: 12 weeks

Emotional Reactivity With the Physiological Measure of Skin Conductance

To assess emotional reactivity with the physiological measure of skin conductance, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.

Time frame: 12 weeks

Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink

To assess emotional reactivity with the physiological measure of startle reflex response by measuring the latency of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.

Time frame: 12 weeks

Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink

To assess emotional reactivity with the physiological measure of startle reflex response - by measuring the amplitude of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.

Time frame: 12 weeks