A Double-Blind Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A Versus Placebo in the Prevention of Relapse of Anxiety up to 1 Year in Patients With GAD Improved After 12 Weeks of Open Label Treatment With SR58611A.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 257
- 试验地点
- 9
- 主要终点
- The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A.
The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period.
The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For entry into the open phase:
- •Patients suffering from generalized anxiety disorder, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and assessed with the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder (GAD) module.
- •With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) > 20 at V1(D-4) and V2 (D-1).
- •For entry into the double-blind randomized phase:
- •Improved patients with HAM-A score < 11 at V7 (W12).
排除标准
- •Inpatients.
- •Patients with a diagnosis of Major Depressive Disorder (DSM IV-TR) within 6 months of screening.
- •Patients with a MADRS total score > 18 at screening or baseline.
- •Patients at immediate risk for suicidal behaviour.
- •Patients with other current (within 6 months) anxiety disorder according to the MINI
- •Patients with a lifetime history according to the MINI of: Bipolar disorder, Psychotic disorder, Antisocial personality disorder.
- •Patients with a current history according to the MINI of: Anorexia nervosa or bulimia nervosa in the past 6 months, Alcohol or substance dependence or abuse in the past 12 months, except nicotine or caffeine dependence.
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
结局指标
主要结局
The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
HAM-A total score ≥ 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or
Any drop-out for lack of efficacy (according to investigator's decision),or
Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.
次要结局
- Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score
- Hamilton Anxiety Rating Scale (HAM-A)