"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

November 17, 2010
May 27, 2014
January 2011
March 2011   (final data collection date for primary outcome measure)
BPD Symptoms [ Time Frame: BPD Symptoms ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01243658 on ClinicalTrials.gov Archive Site
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"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Effects of Oxytocin on Borderline Personality Disorder.
Drug: Oxytocin
Oxytocin
Other Name: Oxytocin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
October 2014
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact: Nicole Ower, Psychologist 0049-761-20397743 Nicole.ower@psychologie.uni-freiburg.de
Germany
 
NCT01243658
OX02
Yes
Prof. Dr. Markus Heinrichs, University of Freiburg
Prof. Dr. Markus Heinrichs
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Study Director: Markus Heinrichs, Prof. Dr. Institut für Psychologie der Univeristät Freiburg
University of Freiburg
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP