Trial document




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  DRKS00000604

Trial Description

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Title

Effects of oxytocin on patients with Borderline Personality Disorder

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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.

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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.

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Organizational Data

  •   DRKS00000604
  •   2010/11/19
  •   [---]*
  •   yes
  •   Approved
  •   307/10, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   2010-020956-69 
  •   4036755 
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Health Condition or Problem studied

  •   F60.31 -  [generalization F60.3: Emotionally unstable personality disorder]
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
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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
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Characteristics

  •   Interventional
  •   [---]*
  •   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)

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Secondary Outcome

- Emotion recognition
- social trust
- rejection sensitivity
- tension
- interpersonel problems
- impulsivity
- disosiation
- mood
- eye-tracking
- cortisol
- heart beat frequence

14 process messure Points

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/12/01
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
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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)

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Exclusion Criteria

- chronic or acute somatic health problems
- Schizophrenia
- Bipolar affective disorder
- pregnancy
- breast feeding
- neurological disorder
- allergy to antidegradants

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Addresses

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    • 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
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    • 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
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    • 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
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Sources of Monetary or Material Support

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    • 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
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.