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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00259272
First received: November 28, 2005
Last updated: April 30, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder I or II
Drug: olanzapine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: Yes ]
  • Increases and Decreases in Fasting Glucose Levels [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to 24 Week Endpoint in Lipids [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: Yes ]
  • Increases and Decreases in Lipid Levels [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to 24 Week Endpoint in Weight [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]
  • Weight Gain Compared to Baseline [ Time Frame: over 24 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment [ Time Frame: Baseline ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Emotional Reactivity With the Physiological Measure of Heart Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Emotional Reactivity With the Physiological Measure of Skin Conductance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: November 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: olanzapine
5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
Other Names:
  • LY170053
  • Velotab
  • Zydis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259272

Locations
France
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, 95580
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.
Bordeaux, France, 33076
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.
Cornebarrieu, France, 31700
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.
Creteil, France, 94010
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.
La Rochelle, France, 17000
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.
La Seyne Sur Mer, France, 83500
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.
Lyon, France, 69322
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.
Marseille, France, 13385
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.
Montpellier, France, 34094
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.
Nimes, France, 30029
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.
Orvault, France, 44700
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.
Paris, France, 75019
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.
Pin Balma, France, 31130
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.
Plaisir, France, 78373
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.
Poitiers, France, 86021
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.
Toulouse, France, 31300
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00259272     History of Changes
Other Study ID Numbers: 9675, F1D-FP-S057
Study First Received: November 28, 2005
Results First Received: April 30, 2009
Last Updated: April 30, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014