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

• Status: Completed
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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)