NCT02043197已完成不适用
Post-Marketing Observational Program of Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorders (FRIENDS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 300
- 试验地点
- 29
- 主要终点
- Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).
研究概览
简要总结
Prospective, multicenter, non-comparative, observational program to describe prevalence of depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the severity of anxiety and depression, sleep state, and cognitive function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Outpatients with neurological disorders and mild or moderate symptoms of depression with Hospital Anxiety Depression Scale (HADS) depression scale score of 8 and higher. Fevarin® prescribed not earlier than 7 days before Visit 1.
排除标准
- •Labeled contraindications to Fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.
结局指标
主要结局
Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).
时间窗: Baseline
The primary neurologic diagnosis was coded according to International Classification of Diseases and Related Health Problems, revision 10 http://apps.who.int/classifications/icd10/browse/2010/en In the report all diseases were summarized by Classes. Percentage of patients reporting at least once a specified symptom during the treatment period.
次要结局
- Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.(From Baseline up to Day 30)
- Gender(Baseline)
- Race(Baseline)
- Percent of Patients With Change of Depression Symptoms From Baseline to Day 30(From Baseline up to Day 30)
- Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score(From Baseline up to Day 30 and Day 90)
- Percent of Patients With Change in Clinical Global Impression Scale(From Baseline up to Day 90)
- Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale(Baseline, Day 90)
- Family Status(Baseline)
- Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score(From Baseline up to Day 30 and Day 90)
- Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS)(Up to 180 days)
- Education(Baseline)
- Employment(Baseline)
研究者
研究点 (29)
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