Botulinumtoxin A for emotional stabilization in borderline personality disorder - BTX-BPD

Medizinische Hochschule Hannover0 sites54 target enrollmentDecember 30, 2015

Overview

No summary available.

Registry

who.int

Start Date

December 30, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Medizinische Hochschule Hannover

•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

•1\. Comorbid disorders of all ICD\-10 groups
•oF1 (with exception of F1x.1\),
•oF3 (with exception of 32\.0 and F33\.0\),
•and disorders essentially defining the clinical picture from sections
•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