EUCTR2005-003181-41-SE
进行中（未招募）
不适用
An eight-week, double-blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy, safety and tolerability of a fixed dose of SR58611A (350 mg q12) in outpatients with Generalized Anxiety Disorder. - NA
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- sanofi-aventis recherche & développement
- 入组人数
- 360
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Out\-patients, 18 to 65 years of age.
- •Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and
- •Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM\-IV\-TR) criteria and
- •confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module.
- •With a total score on the 14\-item Hamilton Anxiety Rating Scale (HAM\-A) \>\= 20\.
- •Having given voluntarily their written informed consent to participate in the study.
- •Able to comply with the protocol and follow written and verbal instructions.
- •Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A. Not placebo
- •responders (i.e., improvement \<\= 20 % on HAM\-A total score between V1 and V2\).
- •Are the trial subjects under 18? no
排除标准
- •Patients with a diagnosis of Major Depressive Disorder as defined by DSM\-IV\-TR within 6 months
- •of study entry.
- •Patients with a Montgomery\-Asberg Depression Rating Scale (MADRS) total score of 18 or
- •higher at screening or baseline.
- •Patients having a current score of \>5 on the suicidal thoughts item of the MADRS at screening or
- •baseline and/or are assessed to have a moderate to high current risk for suicide according to the
- •Patients with other current anxiety disorder (within 6 months) assessed with the MINI:
- •Agoraphobia, social phobia, Panic disorder, Obsessive compulsive disorder, Post\-traumatic
- •stress disorder, acute stress disorder.
- •Patients with a lifetime history according to the MINI of: Bipolar disorders, Psychotic disorders,
结局指标
主要结局
未指定
相似试验
进行中（未招募）
不适用
An eight-week, double-blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy, safety and tolerability of a fixed dose of SR58611A (350 mg q12) in outpatients with Generalized Anxiety Disorder. - NAGeneralized Anxiety Disorder (GAD)MedDRA version: 8.0Level: LLTClassification code 10018105EUCTR2005-003181-41-EEsanofi-aventis recherche & développement360
进行中（未招募）
不适用
An eight-week, double-blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy, safety and tolerability of a fixed dose of SR58611A (350 mg q12) in outpatients with Generalized Anxiety Disorder. - NAGeneralized Anxiety Disorder (GAD)MedDRA version: 8.0Level: LLTClassification code 10018105EUCTR2005-003181-41-ATSanofi-Synthelabo Recherche360
进行中（未招募）
1 期
An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorderEUCTR2007-003159-36-FRsanofi-aventis recherche & développement675
进行中（未招募）
不适用
An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorderEUCTR2007-003159-36-SEsanofi-aventis recherche & développement615
进行中（未招募）
不适用
An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorderEUCTR2007-003159-36-FIsanofi-aventis recherche & développement615