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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00259272

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 III

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

The primary objective of this study is the validation of the Multidimensional Assessment of THYmic States Scale in the overall population and in specific sub-populations as measured by the mean changes from baseline to endpoint. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the relative efficacy of olanzapine in reducing manic, depressive and/or anxiety symptoms as measured by mean change from baseline to endpoint in the Hamilton 17-items Depression Scale. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Assess the relative efficacy of olanzapine in reducing manic, depressive and/or anxiety symptoms as measured by mean change from baseline to endpoint in the Hamilton Anxiety Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Assess the relative efficacy of olanzapine in reducing manic, depressive and/or anxiety symptoms as measured by mean change from baseline to endpoint in the Young Mania Rating Scale. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To collect data on the safety of olanzapine as measured by treatment-emergent adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To collect data on the safety of olanzapine as measured by changes in vital signs (weight) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To collect data on the safety of olanzapine as measured by changes in glycaemia levels. [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
To collect data on the safety of olanzapine as measured by changes in lipid levels. [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
To collect data on the impact of a 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: 23 weeks ] [ Designated as safety issue: No ]
To assess emotional reactivity with the MATHYS scale and to evaluate that manic, hypomanic, mixed states and some bipolar depressions (mixed depression) will be characterized by a hyper-reactivity and pure depressive state by a hypo-reactivity. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To describe the olanzapine efficacy data in patients with hyper-reactivity as defined according to experienced investigators'clinical impression at baseline. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To describe the olanzapine efficacy data in patients with hypo-reactivity, as defined according to experienced investigators' clinical impression at baseline. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To assess the level of hyper/hypo-reactivity during the acute state in each group and to assess the evolution of scores at six months in the maintenance period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To assess emotional reactivity with the physiological measure of startle reflex response, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients. [ 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
A: Experimental	Drug: olanzapine 5 to 20mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Patients must meet 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.

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 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.
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.
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.
Toulouse, France, 31300
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.
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.
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.
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.
Marseille, France, 13385

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9675, F1D-FP-S057
Study First Received:	November 28, 2005
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00259272
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Olanzapine

Mood Disorders
Psychotic Disorders
Depressive Disorder
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009