Clinical trial to evaluate the efficacy of the combination of oxytocin plus self-compassion training in patients with Borderline Personality Disorder
- Conditions
- Borderline personality disorderTherapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2022-003670-22-ES
- Lead Sponsor
- Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
1) Diagnosis of BPD according to two semi-structured interviews (SCID-II and DIB-R).
2) Ages between 18 and 50 years.
3) Stability in the pharmacological treatment during the performance of the intervention.
4) Having undergone previous treatment for BPD with standard TDC or TDC skills training.
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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Present comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain diseases, or mental retardation according to medical examination and clinical evaluation using SCID-I.
2) Present a history of serious endocrinological disorders.
3) Start with another psychotherapy treatment in parallel.
4) Not being in accepted contraceptive treatment.
5) Pregnancy desire or pregnancy planning during the study. The use of accepted contraceptive method will be required except hormonal treatment.
6) Being pregnant or breastfeeding during the study.
7) Being in medical treatment incompatible with the administration of oxytocin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method