Effekte von Oxytocin bei Patientinnen und Patienten mit Borderline-Persönlichkeitsstörung

Phase 1

Active, not recruiting

Conditions: ICD-10 F60.3 Emotionally unstable personality disorderTwo types may be distinguished: the impulsive type, characterized by emotional instability and lack of impulse control, and the borderline type, characterized in addition by disturbances in self-image, aims, and internal preferences, by chronic feelings of emptiness, by intense and unstable interpersonal relationships, self-destructive behaviour, including suicide gestures and attempts.Clinical control group: major depression (ICD-10 F33)
MedDRA version: 17.1Level: PTClassification code 10006034Term: Borderline personality disorderSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 17.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders

Registration Number: EUCTR2010-020956-69-DE

Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

- Borderline personality disorder or major depression (clinical control group)
- 18 - 50 years of age
- Mini Mental Status Test > 27 (capacity to consent)
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- chronic or acute somatic health problems
- Schizophrenia
- Bipolar affective disorder
- pregnancy
- neurological disorder
- allergy to antidegradants

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder.<br>Comparison of the effects of Oxytocin on patients with BPD and major depression.<br>;Primary end point(s): - Symptom severity (Borderline-Symtom-List, Bohus et al., 2007) <br>- Number of criteria in DSM-IV<br>- Severity of depression (Beck-Depression-Inventory, Hautzinger et al., 1994)<br>- Frequency of self-injury<br>- Dropout (early therapy termination) <br>;Main Objective: Main objective of the trial is to examine if oxytocin, compared to placebo shows any additional effect on the therapy achievements (outcome) of patients with borderline personality disorder, who receive an in-patient standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).

Secondary Outcome Measures