A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
研究概览
简要总结
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
详细描述
A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
- •Duration of current episode is at least 12 weeks duration and less than 2 years
- •Symptoms of decreased energy, pleasure, and interest
- •Female subjects who agree to use acceptable methods of birth control throughout the study
- •Exclusion criteria:
- •Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
- •Symptoms of MDE better accounted for by another diagnosis
- •Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
- •Started psychotherapy within 3 months prior to the Screening
- •Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
- •Received psychoactive drugs within 4 weeks of randomization
- •Positive urine drug screen or positive blood alcohol
- •Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
- •Positive pregnancy test
- •History of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition
- •Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
排除标准
- 未提供
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
GSK372475
flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day
干预措施: GSK372475 (Drug)
Venlafaxine
Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day
干预措施: venlafaxine (Drug)
结局指标
主要结局
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
时间窗: Randomisation (week 0) And end of the treatment
次要结局
- Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales(Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase))