Effekte von Oxytocin bei Patientinnen und Patienten mit Borderline-Persönlichkeitsstörung

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020956-69-DE

Enrollment

250

Registered

2010-10-20

Start date

2011-02-23

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD-10 F60.3 Emotionally unstable personality disorder Two 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)

Interventions

Trade Name: Syntocinon-Spray Product Name: Syntocinon-Spray Product Code: Oxytocin Pharmaceutical Form: Nasal spray Pharmaceutical form of the placebo: Nasal spray Route of administration of the place

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression. ;Primary end point(s): - Symptom severity (Borderline-Symtom-List, Bohus et al., 2007) - Number of criteria in DSM-IV - Severity of depression (Beck-Depression-Inventory, Hautzinger et al., 1994) - Frequency of self-injury - Dropout (early therapy termination) ;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)).	—

Measure

Time frame

Secondary Objective: Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression. ;Primary end point(s): - Symptom severity (Borderline-Symtom-List, Bohus et al., 2007) - Number of criteria in DSM-IV - Severity of depression (Beck-Depression-Inventory, Hautzinger et al., 1994) - Frequency of self-injury - Dropout (early therapy termination) ;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)).

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026