NCT00259272已完成3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
A
Experimental
干预措施: olanzapine (Drug)
结局指标
主要结局
Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
时间窗: 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.
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
时间窗: 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.
次要结局
- 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)
- Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score(Baseline, 6 Weeks, 24 Weeks)
- 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)
- Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)(baseline and 24 weeks)
- Increases and Decreases in Fasting Glucose Levels(over 24 weeks)
- Mean Change From Baseline to 24 Week Endpoint in Lipids(Baseline and 24 Weeks)
- Increases and Decreases in Lipid Levels(over 24 weeks)
- Mean Change From Baseline to 24 Week Endpoint in Weight(Baseline and 24 weeks)
- Weight Gain Compared to Baseline(over 24 weeks)
- 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)
- MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment(Baseline)
- Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment(Baseline, 6 Weeks, 24 Weeks)
- 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)
- Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment(Baseline, 6 Weeks, 24 Weeks)
- Emotional Reactivity With the Physiological Measure of Heart Rate(12 weeks)
- Emotional Reactivity With the Physiological Measure of Skin Conductance(12 weeks)
- Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink(12 weeks)
- Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink(12 weeks)
研究者
研究点 (1)
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