A Randomized, Double-blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 538
- 试验地点
- 63
- 主要终点
- Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination
研究概览
简要总结
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient status.
- •A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
- •Depressive symptoms for at least 90 days in single episode and for at least 28 days in recurrent episode before the screening visit.
- •A MADRS total score ≥26 at the screening and baseline visits. And change of MADRS total score at baseline is not over 25% from the screening visit.
- •A QIDS16-J-SR score ≥16 at the screening and baseline visits.
- •A score ≥4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening and baseline visits.
排除标准
- •Subjects who concurrently have Axis II personality disorder or mental retardation according to DSM-IV diagnostic criteria.
- •Subjects who meet DSM-IV criteria for current or past history of Schizophrenia, Paranoid Disorders, or any other Psychotic Disorders.
- •Subjects who meet DSM-IV criteria for current or past history of Dementia.
- •Subjects who meet DSM-IV criteria for current or past history of bipolar disorder, Posttraumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD).
- •Subjects who meet DSM-IV criteria for current (within 12 months before the screening visit) generalized anxiety disorder, panic disorder, or social anxiety disorder considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD).
- •Subjects with a first degree relative with bipolar disorder.
- •Subjects who are actively suicidal.
- •History of non-responsive to 2 antidepressant treatment (at least 6-week usage for each) for the past or current episodes.
- •History of Electroconvulsive therapy (ECT) at any time in the past.
- •History of chronic treatment with benzodiazepines for longer than 6 months before the screening visit (Excluding subjects who have taken PRN benzodiazepine use, < 3 times/week).
- •Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study.
- •Known presence of raised intraocular pressure or history or presence of narrow angle glaucoma.
- •Myocardial infarction within 180 days of the screening visit.
- •Clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG) or laboratory tests.
- •Use of prohibited treatments
研究组 & 干预措施
venlafaxine ER 75 mg/day (fixed dose)
干预措施: venlafaxine ER 75 mg/day (fixed dose) (Drug)
venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
干预措施: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination
时间窗: Baseline, Week 8 or Early termination
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
次要结局
- Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination(Baseline, Week 8 or Early termination)
- Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination(Baseline, Week 8 or Early termination)
- Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination(Baseline, Week 8 or Early termination)
- Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination(Baseline, Week 8 or Early termination)
- Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination(Baseline, Week 8 or Early termination)