EUCTR2008-005424-85-FR进行中（未招募）1 期
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 850 人开始时间: 2009年7月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Open-Label Phase, Screening/Baseline
- •1.Male or female subjects aged 18 years or older.
- •2.Outpatient status.
- •3.A primary diagnosis of MDD, single or recurrent episode, without psychotic features.
- •4.Depressive symptoms for at least 30 days before the screening visit.
- •5.A HAM-D17 total score =20 at the screening visit.
- •6.A score =2 on item 1 (depressed mood) of the HAM-D17 at the screening visit.
- •7.A score =4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening visit.
- •Stability Phase
- •1.Response to treatment, as defined as a HAM-D17 total score of = 11 at the conclusion of the 8-week open-label phase.
- •2. A CGI-I score = 2 at the conclusion of the 8-week open-label phase.
- •Double-Blind Phase
- •1.Maintenance of stability, as defined as a HAM-D17 total score of = 11 at the conclusion of the 12-week stability phase.
- •2. CGI-I score = 2 at the conclusion of the 12-week stability phase,
- •3. Absence of an assessed HAM-D17 total score of = 16 or CGI-I score of = 4 at any visit during the stability phase.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Open-Label Phase, Screening
- •1.Treatment with DVS SR at any time in the past.
- •2.Known or suspected allergy to venlafaxine.
- •3.Significant risk of suicide based on clinical judgment.
- •4.HAM-D17 score =3 on Item 3 (Suicide) at the screening visit.
- •5.Columbia Suicide-Severity Rating Scale (C-SSRS) determination of yes” on question 4 or question 5 for the Suicidal Ideation section at the screening visit.
- •6.Pregnant or breastfeeding women.
- •7.a) Current psychoactive substance abuse or dependence, manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current generalized anxiety disorder, panic disorder, or social anxiety disorder considered by the investigator to be primary; c) presence of a clinically important personality disorder.
- •8.Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
- •9.History of seizure disorder other than a single childhood febrile seizure.
- •10.Any major illness/condition.
- •11.History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
- •12.History of neoplastic disorder (within 2 years), with the exception of basal cell or squamous cell carcinoma of the skin.
- •13.Known presence of raised intraocular pressure or history of narrow angle glaucoma.
- •14.Major acute illness within 90 days of the screening visit.
- •15.Myocardial infarction within 180 days of the screening visit.
- •Open-Label Phase, Baseline
- •1.Clinically important abnormalities indicated by electrocardiograms (ECG), vital signs, laboratory tests or urine drug screening.
- •2.HAM-D17 score =3 on Item 3 (Suicide) at the baseline visit.
- •3.Columbia Suicide-Severity Rating Scale (C-SSRS) determination of yes” on question 4 or question 5 for the Suicidal Ideation section at the baseline visit.
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