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Borderline Personality DisorderPhase 2BTX-BPDNCT02728778

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

A Phase 2 study testing incobotulinumtoxin A and Acupuncture in people with Borderline Personality Disorder, run by Hannover Medical School at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Borderline Personality Disorder
What is being tested?
incobotulinumtoxin A and Acupuncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesGermany
Study dates
1 Sep 2016to 31 Oct 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 9Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Asklepios Klinik Nord-Ochsenzoll

    Hamburg

  • Hannover Medical School

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

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.

Read the 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.

Being tested
incobotulinumtoxin A, Acupuncture
Medical subject headings
Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • incobotulinumtoxin ADrug

    Also called Botox

    Application of botulinum toxin A into the forehead

  • AcupunctureProcedure or surgery

    Application of acupuncture into the forehead

Study groups in NCT02728778
Study groupRoleWhat they receive
Botulinum toxin AActive comparatorSingle administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.
Receives: Drug: incobotulinumtoxin A
AcupunctureOtherPatients will receive four facial acupuncture treatments every two weeks.
Receives: Procedure: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    BPD severity measure expert rating

    Measured: 8 weeks

Secondary outcomes (3)

  1. Borderline symptom list (BSL-23)

    BPD severity measure self rating

    Measured: 4, 8 and 16 weeks

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

    depression severity measure expert rating

    Measured: 4, 8 and 16 weeks

  3. Beck Depression Inventory (BDI)

    depression severity measure self rating

    Measured: 4, 8 and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2016 (estimated)
  2. Study start1 Sep 2016
  3. Primary completion30 Apr 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02728778
Sponsor's protocol ID
V4.11-BTX-BPD
Acronym
BTX-BPD
Status last verified
May 2020
First submitted
31 Mar 2016
Last updated
29 May 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Wollmer MA, Neumann I, Jung S, Bechinie A, Herrmann J, Muller A, Wohlmuth P, Fournier-Kaiser L, Sperling C, Peters L, Kneer J, Engel J, Jurgensen F, Schulze J, Nagel M, Prager W, Sinke C, Kahl KG, Karst M, Dulz B, Kruger THC. Clinical effects of glabellar botulinum toxin injections on borderline personality disorder: A randomized controlled trial. J Psychopharmacol. 2022 Feb;36(2):159-169. doi: 10.1177/02698811211069108. Epub 2022 Feb 1.

    PubMed 35102782

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing incobotulinumtoxin A and Acupuncture in people with Borderline Personality Disorder, run by Hannover Medical School at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Zanarini Scale for Borderline personality disorder (ZAN-BPD) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02728778, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.

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