BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 258
- 试验地点
- 35
- 主要终点
- Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe major depressive disorder
排除标准
- •Prior treatment with botulinum toxin of any serotype for any reason
- •Use of antidepressant medication for depression within 2 weeks of study
- •Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
研究组 & 干预措施
Placebo for onabotulinumtoxinA 50 U
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
干预措施: Normal Saline (Drug)
onabotulinumtoxinA 50 U
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
干预措施: onabotulinumtoxinA (Biological)
Placebo for onabotulinumtoxinA 30 U
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
干预措施: Normal Saline (Drug)
onabotulinumtoxinA 30 U
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
干预措施: onabotulinumtoxinA (Biological)
结局指标
主要结局
Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Week 6
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
次要结局
- Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)(24 Weeks)
- Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score(Baseline)
- Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score(24 Weeks)
- Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)(Baseline)