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

Phase 2

Completed

• Conditions: Borderline Personality Disorder
• Interventions: Drug: incobotulinumtoxin A; Procedure: Acupuncture

• Registration Number: NCT02728778
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-05
• Study Start: 2016-09-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-10-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin A	incobotulinumtoxin A	Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.
Acupuncture	Acupuncture	Patients will receive four facial acupuncture treatments every two weeks.

Primary Outcome Measures

Name	Time	Method
Zanarini Scale for Borderline personality disorder (ZAN-BPD)	8 weeks	BPD severity measure expert rating

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany

Asklepios Klinik Nord-Ochsenzoll; 🇩🇪 Hamburg, Germany