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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 : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Markus Heinrichs, University of Freiburg

Tracking Information
First Submitted Date  ICMJE November 17, 2010
First Posted Date  ICMJE November 18, 2010
Last Update Posted Date November 10, 2020
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
BPD Symptoms [ Time Frame: BPD Symptoms ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Official Title  ICMJE "The Effects of Oxytocin on Patients With Borderline Personality Disorder"
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Effects of Oxytocin on Borderline Personality Disorder
  • Borderline Personality Disorder
Intervention  ICMJE
  • Drug: Oxytocin
    Oxytocin
  • Other: placebo
    placebo
Study Arms  ICMJE
  • Experimental: Oxytocin
    Oxytocin
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2010)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Franny B Spengler, Dr. 0049-761-20397742 franny.spengler@psychologie.uni-freiburg.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01243658
Other Study ID Numbers  ICMJE OX02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Markus Heinrichs, University of Freiburg
Study Sponsor  ICMJE Prof. Dr. Markus Heinrichs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Markus Heinrichs, Prof. Dr. Institut für Psychologie der Univeristät Freiburg
PRS Account University of Freiburg
Verification Date November 2020

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