EUCTR2015-000749-21-DE进行中（未招募）1 期
Botulinumtoxin A for emotional stabilization in borderline personality disorder - BTX-BPD
Medizinische Hochschule Hannover0 个研究点目标入组 54 人开始时间: 2015年12月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •2. 18-40 years
- •3. diagnosed BPD according to ICD-10 (F60.31) and SKID II
- •4. stable treatment
- •5. mastery of the German language
- •6. effective contraception (in accordance to the „note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals, CPMP/ICH/286/95 mod); these inculde contraception methods with a failure rate of less than 1% given correct administration (e.g. hormonal implants, hormonal injections (depot), combined oral contraceptives, IUDs, s/p partners' vasectomy))
- •7. willingness to and acceptance of treatment with either Bocouture or acupuncture
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Comorbid disorders of all ICD-10 groups
- •oF1 (with exception of F1x.1),
- •oF3 (with exception of 32.0 and F33.0),
- •and disorders essentially defining the clinical picture from sections
- •2. Contraindication for treatment with Botulinumtoxin A accoring to the IMP's SmPC (e.g. myasthenia gravis, Lambert Eaton-syndrome or other impairments in neuromuscular function)
- •3. Pregnancy and nursing period
- •4. earlier treatment with Boulinumtoxin A
- •5. acute suicidal tendencies
- •6. severe suicide attempt during the last 6 month
- •7. infections and skin problems at the injection site
- •8. facial nerve palsy in anamnesis
- •9. facial asymmetry
- •10. ptosis
- •11. extremely slack skin
- •12. strong scars
- •13. thick tallowy skin
- •14. acute or anamnestic neurological disorders (esp. s/p stroke and/or TIA
- •15. intake of medication impairing swallowing, speech, breath or affecting salivary production
- •16. different from aesthetically motivated treatment, the Glabella frown line must not be perceived as overly burdening (rating on a 5-point Likert scale) in order to keep influences of a patient's changed perception of her own appearance to a minimum)
- •17. severe health or social problems that call continuous attendance into question
- •18. acute psychotherapeutic structured specific treatment (e.g. DBT)
- •19. intake of medication affecting the muscle tonus
- •20. change of treatment (medication or psychotherapy) less than 8 weeks before inclusion
- •21. participation in other clinical trials (as per AMG) during the last 6 months
- •22. presence of relevant impairment of vigilance (sedation) or muscle tonus (extrapyramidal symptoms) caused by generally permitted medication
研究者
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