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

May 28, 2020 updated by: Prof. Dr. Tillmann Krüger, Hannover Medical School
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Asklepios Klinik Nord-Ochsenzoll
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Botulinum toxin A
Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.
Drug: incobotulinumtoxin A
Application of botulinum toxin A into the forehead
Other Names:
  • Botox
Other: Acupuncture
Patients will receive four facial acupuncture treatments every two weeks.
Procedure: Acupuncture
Application of acupuncture into the forehead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zanarini Scale for Borderline personality disorder (ZAN-BPD)
Time Frame: 8 weeks
BPD severity measure expert rating
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Study Chair: HCTC, Hannover Clinical Trial Center HCTC GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V4.11-BTX-BPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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