Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: incobotulinumtoxin A
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female 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), F2, F3 (with exception of 32.0 and F33.0), F7 and disorders essentially defining the clinical picture from sections F4, F5, F6. 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin A<br>Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites. | Drug: incobotulinumtoxin A<br>* Application of botulinum toxin A into the forehead<br>* Other names: Botox;|
| Other: Acupuncture<br>Patients will receive four facial acupuncture treatments every two weeks. | Procedure: Acupuncture<br>* Application of acupuncture into the forehead<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zanarini Scale for Borderline personality disorder (ZAN-BPD) | BPD severity measure expert rating | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline symptom list (BSL-23) | BPD severity measure self rating | 4, 8 and 16 weeks | 
| Montgomery-Asberg-Depression-Rating-Scale (MADRS) | depression severity measure expert rating | 4, 8 and 16 weeks | 
| Beck Depression Inventory (BDI) | depression severity measure self rating | 4, 8 and 16 weeks |