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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):
Prof. Dr. Markus Heinrichs, University of Freiburg

November 17, 2010
November 18, 2010
December 22, 2017
January 2011
December 2018   (Final data collection date for primary outcome measure)
BPD Symptoms [ Time Frame: BPD Symptoms ]
Not Provided
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"
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Effects of Oxytocin on Borderline Personality Disorder
  • Borderline Personality Disorder
  • Drug: Oxytocin
    Oxytocin
  • Other: placebo
    placebo
  • Experimental: Oxytocin
    Oxytocin
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
June 2019
December 2018   (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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact: Franny B Spengler, Dr. 0049-761-20397742 franny.spengler@psychologie.uni-freiburg.de
Germany
 
 
NCT01243658
OX02
Yes
Not Provided
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Prof. Dr. Markus Heinrichs, University of Freiburg
Prof. Dr. Markus Heinrichs
Not Provided
Study Director: Markus Heinrichs, Prof. Dr. Institut für Psychologie der Univeristät Freiburg
University of Freiburg
December 2017

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