Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Response rate (reduction in Ham-D score by >30% compared to baseline)
研究概览
简要总结
Depression is frequently accompanied by a specific sad facial expression. This expression is in part mediated by the same muscle activity that produces frown lines. Based on the assumption that there is a positive feedback between depressed mood and the correspondent facial muscle activity (facial feedback) the investigators will conduct a randomized controlled pilot study in which the investigators will apply a classical cosmetic treatment of frown lines with injections of botulinum toxin to depressed patients who did not sufficiently respond to antidepressant medication. The investigators hypothesize that this treatment will contribute to the amelioration of depressive symptoms in these patients. This hypothesis is supported by a previous open case series in which remission of depression was reported after such treatment (Finzi and Wasserman, 2006).
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate depression (Ham-D >=15)
- •Therapy with one antidepressant for at least four weeks
- •at least moderate frown line
排除标准
- •Bipolar depression
- •Psychiatric comorbidity
- •Severe somatic comorbidity
- •Pregnancy
- •Peculiarities at the injection site
- •Psychiatric medication other than one antidepressant
- •Specific psychotherapy
- •Previous application of botulinum toxin
- •Medication interfering with botulinum toxin
研究组 & 干预措施
clostridium botulinum toxin type A neurotoxin complex
A total of 20-50 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected at four to six sites in the glabella region according to standard protocols of cosmetic botulinum toxin applications.
干预措施: clostridium botulinum toxin type A neurotoxin complex (Drug)
0.9% sodium chloride NaCl solution
0.9% NaCl solution will be injected like the experimental compound
干预措施: 0.9% NaCl solution (Other)
结局指标
主要结局
Response rate (reduction in Ham-D score by >30% compared to baseline)
时间窗: six weeks
次要结局
- need for additional treatment(eight weeks, twelve weeks, or sixteen weeks)
- Remission rate (number of patients with HAM-D score < 8)(six weeks)
- Time to response (20% reduction of HAM-D score compared to baseline)(two, four, or six weeks)
- response by self rating (BDI)(six weeks)