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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02728778

Acronym

BTX-BPD

Enrollment

Registered

2016-04-05

Start date

2016-09-01

Completion date

2019-10-31

Last updated

2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

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.

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.

Interventions

DRUGincobotulinumtoxin A

Application of botulinum toxin A into the forehead

PROCEDUREAcupuncture

Application of acupuncture into the forehead

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026