"The Effects of Oxytocin on Patients With Borderline Personality Disorder"

Borderline Personality Disorder Clinical Trial

Official title:

"The Effects of Oxytocin on Patients With Borderline Personality Disorder"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243658
• Other study ID #: OX02
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: April 2022

Study information

• Verified date: November 2022
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RCT. Two substudies (clinical and experimental). 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 objectives :

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Gender: Both, male and female

• Minimum Age: 18 Years

• Maximum Age: 50 Years

• Borderline personality disorder or major depression (clinical control group)

• Mini Mental Status Test > 27 (capacity to consent)

Exclusion Criteria:

• chronic or acute somatic health problems

• Schizophrenia

• Bipolar affective disorder

• pregnancy

• breast feeding

• neurological disorder

• allergy to antidegradants

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Effects of Oxytocin on Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• Oxytocin
Oxytocin

Other:
• placebo
placebo

Locations

Country	Name	City	State
Germany	Albert-Ludwigs-Universität-Freiburg	Freiburg	Baden-Würtemberg

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Markus Heinrichs

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BPD Symptoms		BPD Symptoms