"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Primary Purpose
Effects of Oxytocin on Borderline Personality Disorder, Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oxytocin
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Effects of Oxytocin on Borderline Personality Disorder focused on measuring Oxytocin, BPD, Borderline
Eligibility 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
Sites / Locations
- Albert-Ludwigs-Universität-Freiburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxytocin
Placebo
Arm Description
Oxytocin
Placebo
Outcomes
Primary Outcome Measures
BPD Symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT01243658
First Posted
November 17, 2010
Last Updated
November 2, 2022
Sponsor
Prof. Dr. Markus Heinrichs
1. Study Identification
Unique Protocol Identification Number
NCT01243658
Brief Title
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Official Title
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Markus Heinrichs
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of Oxytocin on Borderline Personality Disorder, Borderline Personality Disorder
Keywords
Oxytocin, BPD, Borderline
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Oxytocin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Oxytocin
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
BPD Symptoms
Time Frame
BPD Symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Heinrichs, Prof. Dr.
Organizational Affiliation
Institut für Psychologie der Univeristät Freiburg
Official's Role
Study Director
Facility Information:
Facility Name
Albert-Ludwigs-Universität-Freiburg
City
Freiburg
State/Province
Baden-Würtemberg
ZIP/Postal Code
79104
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
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