Borderline personality disorder
Conditions
Interventions
Trade Name: Bocouture
Product Name: Bocouture (Botulinumtoxin A)
Pharmaceutical Form: Powder for solution for injection
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion 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 (in accordance to the „note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals“, CPMP/ICH/286/95 mod); these inculde contraception methods with a failure rate of less than 1% given correct administration (e.g. hormonal implants, hormonal injections (depot), combined oral contraceptives, IUDs, s/p partners' vasectomy)) 7. willingness to and acceptance of treatment with either Bocouture or acupuncture Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Comorbid disorders of all ICD-10 groups o F0, o F1 (with exception of F1x.1), o F2, o F3 (with exception of 32.0 and F33.0), o F7 and disorders essentially defining the clinical picture from sections o F4, o F5, o F6. 2. Contraindication for treatment with Botulinumtoxin A accoring to the IMP's SmPC (e.g. myasthenia gravis, Lambert Eaton-syndrome or other impairments in neuromuscular function) 3. Pregnancy and nursing period 4. earlier treatment with Boulinumtoxin A 5. acute suicidal tendencies 6. severe suicide attempt during the last 6 month 7. infections and skin problems at the injection site 8. facial nerve palsy in anamnesis 9. facial asymmetry 10. ptosis 11. extremely slack skin 12. strong scars 13. thick tallowy skin 14. acute or anamnestic neurological disorders (esp. s/p stroke and/or TIA 15. intake of medication impairing swallowing, speech, breath or affecting salivary production 16. different from aesthetically motivated treatment, the Glabella frown line must not be perceived as overly burdening (rating on a 5-point Likert scale) in order to keep influences of a patient's changed perception of her own appearance to a minimum) 17. severe health or social problems that call continuous attendance into question 18. acute psychotherapeutic structured specific treatment (e.g. DBT) 19. intake of medication affecting the muscle tonus 20. change of treatment (medication or psychotherapy) less than 8 weeks before inclusion 21. participation in other clinical trials (as per AMG) during the last 6 months 22. presence of relevant impairment of vigilance (sedation) or muscle tonus (extrapyramidal symptoms) caused by generally permitted medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to test whether a single application of botulinumtoxin A into the Glabella will lead to emotional stabilization in borderline personality disorder through paralysis of facial muscles/attenuation of negative emotions.;Secondary Objective: Investigate possible mechanisms of action;Primary end point(s): Zanarini Rating Scale for borderline personality disorder (ZAN-BPD);Timepoint(s) of evaluation of this end point: 8 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Borderline-Symptom-List 23 (BSL-23);Timepoint(s) of evaluation of this end point: 4, 8 and 16 weeks after treatment | — |
Countries
Germany
Contacts
Public ContactHannover Clinical Trial Center GmbH
HCTC GmbH
Outcome results
None listed