COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728778
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Tillmann Krüger, Hannover Medical School

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: incobotulinumtoxin A Procedure: Acupuncture Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Botox
Acupuncture
Patients will receive four facial acupuncture treatments every two weeks.
 Procedure: Acupuncture
Application of acupuncture into the forehead


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Zanarini Scale for Borderline personality disorder (ZAN-BPD) [ Time Frame: 8 weeks ]
    BPD severity measure expert rating


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728778


Locations
Layout table for location information
Germany
Hannover Medical School
Hannover, Lower Saxony, Germany, 30625
Asklepios Klinik Nord-Ochsenzoll
Hamburg, Germany
Sponsors and Collaborators
Hannover Medical School
Investigators
Layout table for investigator information
Study Chair: HCTC Hannover Clinical Trial Center HCTC GmbH
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Prof. Dr. Tillmann Krüger, M.D., Associate Professor, Hannover Medical School
ClinicalTrials.gov Identifier: NCT02728778    
Other Study ID Numbers: V4.11-BTX-BPD
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Personality Disorders
Borderline Personality Disorder
Mental Disorders