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

Borderline Personality Disorder Clinical Trial

— BTX-BPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728778
• Other study ID #: V4.11-BTX-BPD
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2016
• Est. completion date: October 31, 2019

Study information

• Verified date: May 2020
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• incobotulinumtoxin A
Application of botulinum toxin A into the forehead

Procedure:
• Acupuncture
Application of acupuncture into the forehead

Locations

Country	Name	City	State
Germany	Asklepios Klinik Nord-Ochsenzoll	Hamburg
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zanarini Scale for Borderline personality disorder (ZAN-BPD)	BPD severity measure expert rating	8 weeks
Secondary	Borderline symptom list (BSL-23)	BPD severity measure self rating	4, 8 and 16 weeks
Secondary	Montgomery-Asberg-Depression-Rating-Scale (MADRS)	depression severity measure expert rating	4, 8 and 16 weeks
Secondary	Beck Depression Inventory (BDI)	depression severity measure self rating	4, 8 and 16 weeks