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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Freiburg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Markus Heinrichs, University of Freiburg
ClinicalTrials.gov Identifier:
NCT01243658
First received: November 17, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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: October 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxytocin
    Oxytocin
    Other Name: Oxytocin
  Eligibility

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

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

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

Locations
Germany
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
Investigators
Study Director: Markus Heinrichs, Prof. Dr. Institut für Psychologie der Univeristät Freiburg
  More Information

No publications provided

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: May 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by University of Freiburg:
Oxytocin
BPD
Borderline

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Disease
Mental Disorders
Pathologic Processes
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014