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Trial record 24 of 275 for:    personality AND therapy AND Personality | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02728778
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Tillmann Krüger, Hannover Medical School

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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)

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


Contacts
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Contact: Tillmann Krüger, MD, Prof. 0049 511 532 2407 krueger.tillmann@mh-hannover.de
Contact: M. Axel Wollmer, MD 0049 40 181887 2372 m.wollmer@asklepios.com

Locations
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Germany
Hannover Medical School Recruiting
Hannover, Lower Saxony, Germany, 30625
Contact: Tillmann HC Kruger, MD    0049-511-532-2407    borderline@mh-hannover.de   
Asklepios Klinik Nord-Ochsenzoll Recruiting
Hamburg, Germany
Contact: Axel Wollmer, MD    0049-40-181887-2337    m.wollmer@asklepios.com   
Sponsors and Collaborators
Hannover Medical School
Investigators
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Study Chair: HCTC Hannover Clinical Trial Center HCTC GmbH

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Responsible Party: Prof. Dr. Tillmann Krüger, M.D., Associate Professor, Hannover Medical School
ClinicalTrials.gov Identifier: NCT02728778     History of Changes
Other Study ID Numbers: V4.11-BTX-BPD
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Disease
Pathologic Processes
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents