Phase 3
Completed N=141
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
Bipolar Disorder I or II
Source: ClinicalTrials.gov NCT00259272 ↗
Enrolled (actual)
141
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score — 140.55; 136.52; 116.74; 76.88 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score |
140.55; 136.52; 116.74; 76.88; 115.37; 105.15 | — |
| PRIMARY Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix |
8.77; 0.4383; 0.4383; 2.01; 0.1006; 0.5389 | — |
| SECONDARY Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score |
6.46; 8.43; 12.65; 16.06; -1.79; -3.10 | — |
| SECONDARY Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score |
7.78; 11.94; 15.46; 15.08; -2.68; -5.48 | — |
| SECONDARY Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score |
24.50; 17.84; 12.96; 2.78; -13.65; -13.13 | — |
| SECONDARY Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) |
89.27; 85.99; 85.94; 88.52; -3.07; 4.65 | — |
| SECONDARY Increases and Decreases in Fasting Glucose Levels |
5; 9; 3; 10; 4; 8 | — |
| SECONDARY Mean Change From Baseline to 24 Week Endpoint in Lipids |
182.88; 191.55; 210.51; 203.77; 23.64; 2.26 | — |
| SECONDARY Increases and Decreases in Lipid Levels |
18; 7; 11; 20; 11; 9 | — |
| SECONDARY Mean Change From Baseline to 24 Week Endpoint in Weight |
1.37; 1.91; 1.78; 2.15 | — |
| SECONDARY Weight Gain Compared to Baseline |
30; 26; 18; 42; 0; 0 | — |
| 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) |
8; 16; 6; 10; 5; 2 | — |
| SECONDARY MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment |
81.24; 122.49; 117.26 | — |
| SECONDARY Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment |
12.87; 12.63; 11.40; -4.93; -5.96; -4.30 | — |
| SECONDARY Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment |
14.48; 10.64; 9.50; -6.61; -4.89; -4.00 | — |
| SECONDARY Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment |
4.48; 16.50; 10.00; -2.38; -10.45; -6.50 | — |
| SECONDARY Emotional Reactivity With the Physiological Measure of Heart Rate |
— | — |
| SECONDARY Emotional Reactivity With the Physiological Measure of Skin Conductance |
— | — |
| SECONDARY Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink |
— | — |
| SECONDARY Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00259272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.