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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Freiburg
Information provided by (Responsible Party):
Prof. Dr. Markus Heinrichs, University of Freiburg
ClinicalTrials.gov Identifier:
First received: November 17, 2010
Last updated: December 8, 2014
Last verified: December 2014

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.

Condition Intervention
Effects of Oxytocin on Borderline Personality Disorder.
Drug: Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by University of Freiburg:

Primary Outcome Measures:
  • BPD Symptoms [ Time Frame: BPD Symptoms ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxytocin

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243658

Contact: Nicole Ower, Psychologist 0049-761-20397743 Nicole.ower@psychologie.uni-freiburg.de

Albert-Ludwigs-Universität-Freiburg Recruiting
Freiburg, Baden-Würtemberg, Germany, 79104
Contact: Nicole Ower, Psychologist    0049-761-20397743    Nicole.ower@psychologie.uni-freiburg.de   
Sponsors and Collaborators
Prof. Dr. Markus Heinrichs
Study Director: Markus Heinrichs, Prof. Dr. Institut für Psychologie der Univeristät Freiburg
  More Information

Responsible Party: Prof. Dr. Markus Heinrichs, University of Freiburg
ClinicalTrials.gov Identifier: NCT01243658     History of Changes
Other Study ID Numbers: OX02 
Study First Received: November 17, 2010
Last Updated: December 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by University of Freiburg:

Additional relevant MeSH terms:
Borderline Personality Disorder
Personality Disorders
Mental Disorders
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 26, 2016