.a.

Phase 1

• Conditions: Borderline personality disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-000749-21-DE
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 54

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

1. Comorbid disorders of all ICD-10 groups
oF0,
oF1 (with exception of F1x.1),
oF2,
oF3 (with exception of 32.0 and F33.0),
oF7
and disorders essentially defining the clinical picture from sections
oF4,
oF5,
oF6.
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified