NCT02728778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

2.7 years

First QC Date

March 31, 2016

Last Update Submit

May 28, 2020

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • Zanarini Scale for Borderline personality disorder (ZAN-BPD)

    BPD severity measure expert rating

    8 weeks

Secondary Outcomes (3)

  • Borderline symptom list (BSL-23)

    4, 8 and 16 weeks

  • Montgomery-Asberg-Depression-Rating-Scale (MADRS)

    4, 8 and 16 weeks

  • Beck Depression Inventory (BDI)

    4, 8 and 16 weeks

Study Arms (2)

Botulinum toxin A

ACTIVE COMPARATOR

Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites.

Drug: incobotulinumtoxin A

Acupuncture

OTHER

Patients will receive four facial acupuncture treatments every two weeks.

Procedure: Acupuncture

Interventions

incobotulinumtoxin ADRUG

Application of botulinum toxin A into the forehead

Also known as: Botox
Botulinum toxin A
AcupuncturePROCEDURE

Application of acupuncture into the forehead

Acupuncture

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Asklepios Klinik Nord-Ochsenzoll

Hamburg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35102782DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Botulinum Toxins, Type AAcupuncture Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsComplementary TherapiesTherapeutics

Study Officials

  • HCTC

    Hannover Clinical Trial Center HCTC GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Associate Professor

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 5, 2016

Study Start

September 1, 2016

Primary Completion

April 30, 2019

Study Completion

October 31, 2019

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

DE(2)