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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin A | Active Comparator | Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites. |
|
| Acupuncture | Other | Patients will receive four facial acupuncture treatments every two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incobotulinumtoxin A | Drug | Application of botulinum toxin A into the forehead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Zanarini Scale for Borderline personality disorder (ZAN-BPD) | BPD severity measure expert rating | 8 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Comorbid disorders of all ICD-10 groups o F0,
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)
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| Name | Affiliation | Role |
|---|---|---|
| HCTC | Hannover Clinical Trial Center HCTC GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | Lower Saxony | 30625 | Germany | ||
| Asklepios Klinik Nord-Ochsenzoll |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35102782 | Derived | Wollmer MA, Neumann I, Jung S, Bechinie A, Herrmann J, Muller A, Wohlmuth P, Fournier-Kaiser L, Sperling C, Peters L, Kneer J, Engel J, Jurgensen F, Schulze J, Nagel M, Prager W, Sinke C, Kahl KG, Karst M, Dulz B, Kruger THC. Clinical effects of glabellar botulinum toxin injections on borderline personality disorder: A randomized controlled trial. J Psychopharmacol. 2022 Feb;36(2):159-169. doi: 10.1177/02698811211069108. Epub 2022 Feb 1. |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Acupuncture | Procedure | Application of acupuncture into the forehead |
|
| 4, 8 and 16 weeks |
| Beck Depression Inventory (BDI) | depression severity measure self rating | 4, 8 and 16 weeks |
| Hamburg |
| Germany |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |