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

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
incobotulinumtoxin A
Acupuncture
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Hannover Medical School
  • Asklepios Klinik Nord-Ochsenzoll

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Botulinum toxin A

Acupuncture

Arm Description

Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.

Patients will receive four facial acupuncture treatments every two weeks.

Outcomes

Primary Outcome Measures

Zanarini Scale for Borderline personality disorder (ZAN-BPD)
BPD severity measure expert rating

Secondary Outcome Measures

Borderline symptom list (BSL-23)
BPD severity measure self rating
Montgomery-Asberg-Depression-Rating-Scale (MADRS)
depression severity measure expert rating
Beck Depression Inventory (BDI)
depression severity measure self rating

Full Information

First Posted
March 31, 2016
Last Updated
May 28, 2020
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02728778
Brief Title
Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Acronym
BTX-BPD
Official Title
Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin A
Arm Type
Active Comparator
Arm Description
Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.
Arm Title
Acupuncture
Arm Type
Other
Arm Description
Patients will receive four facial acupuncture treatments every two weeks.
Intervention Type
Drug
Intervention Name(s)
incobotulinumtoxin A
Other Intervention Name(s)
Botox
Intervention Description
Application of botulinum toxin A into the forehead
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Application of acupuncture into the forehead
Primary Outcome Measure Information:
Title
Zanarini Scale for Borderline personality disorder (ZAN-BPD)
Description
BPD severity measure expert rating
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Borderline symptom list (BSL-23)
Description
BPD severity measure self rating
Time Frame
4, 8 and 16 weeks
Title
Montgomery-Asberg-Depression-Rating-Scale (MADRS)
Description
depression severity measure expert rating
Time Frame
4, 8 and 16 weeks
Title
Beck Depression Inventory (BDI)
Description
depression severity measure self rating
Time Frame
4, 8 and 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HCTC
Organizational Affiliation
Hannover Clinical Trial Center HCTC GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Name
Asklepios Klinik Nord-Ochsenzoll
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35102782
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.
Results Reference
derived

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

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