Trial document
DRKS00000604
Trial Description
Title
Effects of oxytocin on patients with Borderline Personality Disorder
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
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.
Brief Summary in Scientific Language
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00000604
- 2010/11/19
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- yes
- Approved
- 307/10, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
Secondary IDs
- 2010-020956-69
- 4036755
Health Condition or Problem studied
- F60.31 - [generalization F60.3: Emotionally unstable personality disorder]
- F33.1 - Recurrent depressive disorder, current episode moderate
Interventions/Observational Groups
-
Syntocinon-Spray (Novartis)
active substance: Oxytocin
4x singel dose of 24 I.U. (before the experiments)
For the period of 8 weeks 3 x a day 20 I.U. (max. daily dose of 60 I.E.) -
Placebo-Spray
same dose as arm 1
Characteristics
- Interventional
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- Randomized controlled trial
- Double or multiple blind
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- Placebo
- Other
- Factorial
- N/A
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Primary Outcome
- Symptom severity (Borderline-Symtom-List, Bohus et al., 2007)
- Number of criteria in DSM-IV
- Severity of depression (Beck-Depression-Inventory, Hautzinger et al., 1994)
- Frequency of self-injury
- Dropout (early therapy termination)
Secondary Outcome
- Emotion recognition
- social trust
- rejection sensitivity
- tension
- interpersonel problems
- impulsivity
- disosiation
- mood
- eye-tracking
- cortisol
- heart beat frequence
14 process messure Points
Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Planned
- 2010/12/01
- 250
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 50 Years
Additional Inclusion Criteria
- Borderline personality disorder or major depression (clinical control group)
- 18 - 50 years of age
- 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
Addresses
-
start of 1:1-Block address primary-sponsor
- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Mr. Prof. Dr. Markus Heinrichs
- Stefan-Meier-Str. 8
- 79104 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0761-203-3029
- 0761-203-3023
- heinrichs at psychologie.uni-freiburg.de
- http://www.psychologie.uni-freiburg.de/
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Ms. Dipl.-Psych. Nicole Ower
- Stefan-Meier-Strasse 8
- 79104 Freibrug
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0761-203-97743
- 0761-203-3023
- Nicole.ower at psychologie.uni-freiburg.de
- http://www.psychologie.uni-freiburg.de/
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Ms. Dipl.-Psych. Nicole Ower
- Stefan-Meier-Str. 8
- 79104 Freibrug
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0761-20397743
- 0761-203-3023
- Nicole.ower at psychologie.uni-freiburg.de
- http://www.psychologie.uni-freiburg.de/
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Mr. Prof. Dr. Markus Heinrichs
- Stefan-Meier-Str. 8
- 79104 Freiburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0761-203-3029
- 0761-203-3023
- heinrichs at psychologie.uni-freiburg.de
- http://www.psychologie.uni-freiburg.de/
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
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Trial Publications, Results and other Documents
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