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OpenTrials
Completed

NCT Number: NCT00259272

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

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.

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Key information

Conditions

Bipolar Disorder I or II

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Olanzapine

Drug

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

Other names: LY170053, Velotab, Zydis

Primary outcomes

  1. 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

    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.

  2. Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix

    Time frame: Baseline

    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.

Secondary outcomes

  1. 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

    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).

  2. 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

    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).

  3. 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

    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.

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

    Time frame: baseline and 24 weeks

  5. Increases and Decreases in Fasting Glucose Levels

    Time frame: over 24 weeks

  6. Mean Change From Baseline to 24 Week Endpoint in Lipids

    Time frame: Baseline and 24 Weeks

    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).

  7. Increases and Decreases in Lipid Levels

    Time frame: over 24 weeks

  8. Mean Change From Baseline to 24 Week Endpoint in Weight

    Time frame: Baseline and 24 weeks

  9. Weight Gain Compared to Baseline

    Time frame: over 24 weeks

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

  10. 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

  11. MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment

    Time frame: Baseline

    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.

  12. 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

    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).

  13. 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

    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).

  14. 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

    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.

  15. Emotional Reactivity With the Physiological Measure of Heart Rate

    Time frame: 12 weeks

    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

  16. Emotional Reactivity With the Physiological Measure of Skin Conductance

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 29, 2005
Registry last updated
Jun 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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