Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Zanarini Scale for Borderline personality disorder (ZAN-BPD)
研究概览
简要总结
The main objective of the trial is to test whether a single application of botulinum toxin A into the glabellar region will lead to emotional stabilization in borderline personality disorder through paralysis of facial muscles/attenuation of negative emotions.
详细描述
Afferent feedback from facial muscles is believed to enhance emotional states (facial feedback theory). The facial expression of negative emotions involves facial muscles of the glabellar region. It has been shown that paralysis of facial muscles in the forehead using botulinum toxin A leads to the improvement of depressive symptoms. It is believed that the limited ability to express these emotions alleviates depressive symptoms. As Borderline personality disorder is characterized by negative emotions expressed via facial muscles in the forehead, it is hypothesized that BPD patients could profit from botulinum toxin treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-40 years
- •diagnosed BPD according to ICD-10 (F60.31) and SKID II
- •stable treatment
- •mastery of the German language
- •effective contraception
- •willingness to and acceptance of treatment with either botulinum toxin A or acupuncture
排除标准
- •Comorbid disorders of all ICD-10 groups o F0,
- •F1 (with exception of F1x.1),
- •F3 (with exception of 32.0 and F33.0),
- •F7 and disorders essentially defining the clinical picture from sections
- •Contraindication for treatment with botulinum toxin A according to the IMP's SmPC (e.g. myasthenia gravis, Lambert Eaton-syndrome or other impairments in neuromuscular function)
研究组 & 干预措施
Botulinum toxin A
Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.
干预措施: incobotulinumtoxin A (Drug)
Acupuncture
Patients will receive four facial acupuncture treatments every two weeks.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Zanarini Scale for Borderline personality disorder (ZAN-BPD)
时间窗: 8 weeks
BPD severity measure expert rating
次要结局
- Borderline symptom list (BSL-23)(4, 8 and 16 weeks)
- Montgomery-Asberg-Depression-Rating-Scale (MADRS)(4, 8 and 16 weeks)
- Beck Depression Inventory (BDI)(4, 8 and 16 weeks)
研究者
Prof. Dr. Tillmann Krüger
M.D., Associate Professor
Hannover Medical School