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NCT01243658 Clinical Trial

"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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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