Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 主要终点
- Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12
研究概览
简要总结
This study is planned to evaluate emotional disorders during treatment by interferon (IFN) beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label exploratory study with no change of therapeutic behavior but with standardized neuropsychologic follow-up.
详细描述
This study is planned to evaluate emotional disorders during treatment by IFN beta in RRMS subjects. This is an open-label, prospective, interventional, multicentric study with no change of therapeutic behavior but with standardized neuropsychologic follow-up. Subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (Baseline, Day 7 and 15) and 10 evaluations after the treatment (Month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).
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
- •Male and female subjects aged ≥ 18 years
- •Subjects with RRMS
- •Subjects with at least 2 relapses in the past two years (with last relapse finished or finishing)
- •Subjects with indication of IFN beta treatment determined by the investigator
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Subjects with secondary progressive multiple sclerosis (MS) without relapse
- •Subjects with ongoing acute relapse
- •Subjects already being treated with interferon
- •Subjects with corticoid therapy for less than 15 days
- •Subjects presenting acute major depression or treated with anti-depressant therapy
- •Subjects involved in another therapeutic study
- •Subjects with any condition which could interfere with a good compliance of this study
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12
时间窗: Baseline and Month 12
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18
时间窗: Baseline and Month 18
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24
时间窗: Baseline and Month 24
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
次要结局
- Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24(Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24)
- Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24(Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24)
- Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24(Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24)
- Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24(Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24)
- Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24(Baseline, Months 1, 2, 3, 6, 12, and 24)