Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Overview
- Phase
- Phase 2
- Intervention
- incobotulinumtoxin A
- Conditions
- Borderline Personality Disorder
- Sponsor
- Hannover Medical School
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Zanarini Scale for Borderline personality disorder (ZAN-BPD)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Prof. Dr. Tillmann Krüger
M.D., Associate Professor
Hannover Medical School
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Botulinum toxin A
Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.
Intervention: incobotulinumtoxin A
Acupuncture
Patients will receive four facial acupuncture treatments every two weeks.
Intervention: Acupuncture
Outcomes
Primary Outcomes
Zanarini Scale for Borderline personality disorder (ZAN-BPD)
Time Frame: 8 weeks
BPD severity measure expert rating
Secondary Outcomes
- 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)