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Trial record 1 of 2 for:    heinrichs oxytocin
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"The Effects of Oxytocin on Patients With Borderline Personality Disorder"

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ClinicalTrials.gov Identifier: NCT01243658
Recruitment Status : Recruiting
First Posted : November 18, 2010
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Effects of Oxytocin on Borderline Personality Disorder Borderline Personality Disorder Drug: Oxytocin Other: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: "The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Study Start Date : January 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Oxytocin
Oxytocin
Drug: Oxytocin
Oxytocin
Placebo Comparator: Placebo
Placebo
Other: placebo
placebo


Outcome Measures

Primary Outcome Measures :
  1. BPD Symptoms [ Time Frame: BPD Symptoms ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243658


Contacts
Contact: Franny B Spengler, Dr. 0049-761-20397742 franny.spengler@psychologie.uni-freiburg.de

Locations
Germany
Albert-Ludwigs-Universität-Freiburg Recruiting
Freiburg, Baden-Würtemberg, Germany, 79104
Contact: Franny B Spengler, Dr.    0049-761-20397742    franny.spengler@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

Responsible Party: Prof. Dr. Markus Heinrichs, University of Freiburg
ClinicalTrials.gov Identifier: NCT01243658     History of Changes
Other Study ID Numbers: OX02
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by Prof. Dr. Markus Heinrichs, University of Freiburg:
Oxytocin
BPD
Borderline

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