Bipolar Disorder I or II Clinical Trial
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.
| Status | Completed |
| Enrollment | 141 |
| Est. completion date | May 2008 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score | Baseline, 6 Weeks, 24 weeks | No | |
| Primary | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Baseline | No | |
| Secondary | Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score | Baseline, 6 Weeks, 24 Weeks | No | |
| Secondary | Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score | Baseline, 6 Weeks, 24 Weeks | No | |
| Secondary | Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score | Baseline, 6 Weeks, 24 Weeks | No | |
| Secondary | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | baseline and 24 weeks | Yes | |
| Secondary | Increases and Decreases in Fasting Glucose Levels | over 24 weeks | Yes | |
| Secondary | Mean Change From Baseline to 24 Week Endpoint in Lipids | Baseline and 24 Weeks | Yes | |
| Secondary | Increases and Decreases in Lipid Levels | over 24 weeks | Yes | |
| Secondary | Mean Change From Baseline to 24 Week Endpoint in Weight | Baseline and 24 weeks | Yes | |
| Secondary | Weight Gain Compared to Baseline | over 24 weeks | Yes | |
| Secondary | Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline) | 24 weeks | No | |
| Secondary | MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment | Baseline | No | |
| Secondary | Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment | Baseline, 6 Weeks, 24 Weeks | No | |
| Secondary | Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment | Baseline, 6 Weeks, 24 Weeks | No | |
| Secondary | Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment | Baseline, 6 Weeks, 24 Weeks | No | |
| Secondary | Emotional Reactivity With the Physiological Measure of Heart Rate | 12 weeks | No | |
| Secondary | Emotional Reactivity With the Physiological Measure of Skin Conductance | 12 weeks | No | |
| Secondary | Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink | 12 weeks | No | |
| Secondary | Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink | 12 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01430455 -
Tranylcypromine Treatment of Bipolar Depression
|
Phase 4 |