A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 20
- 主要终点
- Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
研究概览
简要总结
The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18-65 years old
- •Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder
- •The patient's current depressive episode must be at least 4 weeks in duration
排除标准
- •Women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing potential who are not practicing a reliable method of birth control
- •Patients with a history of meeting DSM-IV-TR criteria for:
- •any manic or hypomanic episode;
- •schizophrenia or any other psychotic disorder;
- •obsessive-compulsive disorder.
- •Patients who are considered a suicide risk
研究组 & 干预措施
1
40 -120 mg/day Levomilnacipran ER capsules, oral administration
干预措施: Levomilnacipran ER (Drug)
2
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing
干预措施: Paroxetine, Sertraline, Citalopram or Fluoxetine. (Drug)
3
Matching placebo capsules, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
时间窗: From Baseline to Week 8
The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued
Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
时间窗: From Baseline to Week 8
The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.
次要结局
- Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward(From Baseline to Week 8)