NCT00285376已完成3 期
A Randomized, Double-Blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 10
- 主要终点
- MADRS
研究概览
简要总结
This study is designed to determine the safety and effectiveness of vilazodone for major depressive disorder and to discover genetic markers associated with response. This study will enroll approximately 400 patients.
详细描述
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 400 patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18-65 years of age, inclusive.
- •A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.
- •HAM-D score ≥
- •HAM-D item 1 (depressed mood) score ≥
- •Patients must be able to provide written informed consent to participate before beginning any trial related activities.
- •Patients must be able to speak, read and understand English and possess the ability to respond to questions and follow simple instructions.
排除标准
- •A current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder (Generalized Anxiety Disorder, Social Phobia or Simple Phobia will be allowed).
- •A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
- •DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
- •Criteria for any of the following DSM-IV-TR MDD Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern.
研究组 & 干预措施
1
Experimental
vilazodone
干预措施: vilazodone (Drug)
2
Placebo Comparator
干预措施: vilazodone (Drug)
结局指标
主要结局
MADRS
时间窗: 8 weeks
次要结局
- HAM-D(8 weeks)
- CGI(8 weeks)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54861911 in Healthy Elderly ParticipantsHealthyNCT01887535Janssen Research & Development, LLC70
进行中（未招募）
1 期
The OPERa study to assess the effectiveness and safety of Olaparib with Paclitaxel, in Western patients with advanced gastric and gastro-oesophageal junction cancerAdvanced Gastric and Gastro-oesophageal cancerMedDRA version: 18.0 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10017760 Term: Gastric cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10017768 Term: Gastric cancer stage IV without metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10066350 Term: Adenocarcinoma of the gastrooesophageal junction System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10017761 Term: Gastric cancer recurrent System Organ Class:EUCTR2015-001605-14-GBThe Royal Marsden NHS Foundation Trust154
进行中（未招募）
不适用
a Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures. ELEVATE: ELtrombopag EValuated for its Ability to overcome Thrombocytopenia and Enable procedures - ELEVATEthrombocytopenic subjects with Chronic Liver Disease Undergoing Elective Invasive ProceduresMedDRA version: 9.1Level: HLTClassification code 10043555Term: ThrombocytopeniasMedDRA version: 9.1Level: HLTClassification code 10027681Term: Hepatic and hepatobiliary disorders NECEUCTR2007-005851-40-ITGlaxoSmithKline Research and Development Ltd500
进行中（未招募）
1 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia. - RED-HF Trial – Reduction of Events with Darbepoetin alfa in Heart Failure TrialHeart Failure Subjects with Symptomatic Left Ventricular Systolic Dysfunction and AnemiaMedDRA version: 8.1 Level: PT Classification code 10007559 Term: Cardiac failure congestiveEUCTR2005-005278-59-GBAmgen Inc.2,600
进行中（未招募）
不适用
A Double-blind, Randomized, Placebo-controlled, Multicenter Study toAssess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality andMorbidity in Heart Failure (HF) Subjects with Symptomatic Left VentricularSystolic Dysfunction and Anemia. - RED-HF Trial – Reduction of Events with Darbepoetin alfa in Heart Failure TrialHeart Failure Subjects with Symptomatic Left Ventricular Systolic Dysfunction and AnemiaMedDRA version: 8.1Level: PTClassification code 10007559EUCTR2005-005278-59-IEAmgen Inc.3,400