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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Botulinum toxin A

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

Group Type ACTIVE_COMPARATOR

incobotulinumtoxin A

Intervention Type DRUG

Application of botulinum toxin A into the forehead

Acupuncture

Patients will receive four facial acupuncture treatments every two weeks.

Group Type OTHER

Acupuncture

Intervention Type PROCEDURE

Application of acupuncture into the forehead

Interventions

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incobotulinumtoxin A

Application of botulinum toxin A into the forehead

Intervention Type DRUG

Acupuncture

Application of acupuncture into the forehead

Intervention Type PROCEDURE

Other Intervention Names

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Botox

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No