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Completed

NCT Number: NCT02728778

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

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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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hannover Medical School, Hanover, Lower Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

incobotulinumtoxin A

Drug

Application of botulinum toxin A into the forehead

Other names: Botox

Acupuncture

Procedure

Application of acupuncture into the forehead

Primary outcomes

  1. Zanarini Scale for Borderline personality disorder (ZAN-BPD)

    Time frame: 8 weeks

    BPD severity measure expert rating

Secondary outcomes

  1. Borderline symptom list (BSL-23)

    Time frame: 4, 8 and 16 weeks

    BPD severity measure self rating

  2. Montgomery-Asberg-Depression-Rating-Scale (MADRS)

    Time frame: 4, 8 and 16 weeks

    depression severity measure expert rating

  3. Beck Depression Inventory (BDI)

    Time frame: 4, 8 and 16 weeks

    depression severity measure self rating

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Acronym: BTX-BPD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2016
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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