A Double-blind, Placebo-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 518
- 试验地点
- 14
- 主要终点
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
研究概览
简要总结
The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18-70 years of age.
- •Currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
- •The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.
排除标准
- •Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
- •Patients with a history of meeting DSM-IV-TR criteria for any:
- •manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
- •any depressive episode with psychotic or catatonic features;
- •panic disorder with or without agoraphobia;
- •obsessive-compulsive disorder;
- •schizophrenia, schizoaffective, or other psychotic disorder;
- •bulimia or anorexia nervosa;
- •presence of borderline personality disorder or antisocial personality disorder;
- •mental retardation, dementia, amnesia, or other cognitive disorders;
- •patients who are considered a suicide risk.
研究组 & 干预措施
Dose-matched placebo
Participants received dose-matched placebo orally once daily for 9 weeks.
干预措施: Dose-matched placebo (Drug)
Vilazodone
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
干预措施: Vilazodone (Drug)
结局指标
主要结局
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
时间窗: Baseline to Week 8
The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.
次要结局
- Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8(Baseline to Week 8)
- Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate(Baseline to Week 8)