NCT00636246已完成2 期
Sertraline/[S,S]-Reboxetine Combination Versus Sertraline And [S,S]-Reboxetine Monotherapy In Major Depressive Disorder (MDD) In A Double-Blind, Placebo-Controlled, Eight Week Study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness.
研究概览
简要总结
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.
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
- Double (Participant, Investigator)
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
- •Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I.
- •HAM-D (17-item) ≥ 22 at Screening (Visit 1) and > 20 at Baseline (Visit 2).
- •Minimum CGI-S ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2).
排除标准
- •Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs.
- •Subjects with > 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
- •Subjects with uncorrected hypothyroidism or hyperthyroidism.
研究组 & 干预措施
Sertraline/[S,S]-Reboxetine-satellite150/4
Experimental
干预措施: sertraline/[S,S]-reboxetine (Drug)
Sertraline/[S,S]-Reboxetine-satellite150/6
Experimental
干预措施: sertraline/[S,S]-reboxetine (Drug)
sertraline-satellite
Active Comparator
干预措施: sertraline (Drug)
sertraline-main
Active Comparator
干预措施: sertraline (Drug)
Sertraline/[S,S]-Reboxetine-satellite150/2
Experimental
干预措施: sertraline/[S,S]-reboxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Sertraline/[S,S]-Reboxetine-main
Experimental
干预措施: sertraline/[S,S]-reboxetine (Drug)
[S,S]-reboxetine-main
Active Comparator
干预措施: [S,S]-reboxetine monotherapy (Drug)
结局指标
主要结局
The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness.
时间窗: visits 1-9
次要结局
- Change from Baseline in HAM-D (17-item) total score(Weeks 1, 2, 3, 5, 6, and 8)
- Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)(Weeks 5 and 8)
- The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.(Weeks 1, 2, 3, 5, 6, and 8)
- Change from Baseline in MADRS total score(Weeks 1, 2, 3, 5, 6, and 8)
研究者
研究点 (1)
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