Clinical trial NCT02728778: Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Official title: Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. female
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
7. willingness to and acceptance of treatment with either botulinum toxin A or acupuncture

Exclusion Criteria:

1. 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.
2. 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)

Primary outcomes:
measure: Zanarini Scale for Borderline personality disorder (ZAN-BPD)
timeFrame: 8 weeks
Secondary outcomes:
measure: Borderline symptom list (BSL-23)
timeFrame: 4, 8 and 16 weeks
measure: Montgomery-Asberg-Depression-Rating-Scale (MADRS)
timeFrame: 4, 8 and 16 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 4, 8 and 16 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
city: Hamburg
country: Germany
facility: Asklepios Klinik Nord-Ochsenzoll
Study officials:
affiliation: Hannover Clinical Trial Center HCTC GmbH
name: HCTC
role: STUDY_CHAIR
References:
citation: 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.