Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009399

Trial Description

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Title

Effects of oxytocin on stress reactivity during a Traumatic Reminder in patients with posttraumatic stress disorder

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Trial Acronym

OXY-Trauma

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study investigates the impact of Oxytocin on stress reactions in 35 female patients with posttraumatic stress disorders. Therefore bodily stress reactions are measured via Impedance Cardiographie and subjective stress reactions are measure by questionnaires during listening of an individual description of a traumatic event.

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Brief Summary in Scientific Language

Oxytocin not only promotes social behavior in human but potentially also mediates acute stress reactions. In a randomized controlled design, 35 female participants with PTSD underwent two subsequent experimental stress tests receiving either 24 IU Oxytocin via nasal spray or placebo. Heart rate (HR), heart rate variability (HRV), and pre-ejection period (PEP) were monitored via impedance cardiography during listening to an audiotaped description of an individual traumatic event. Script related subjective stress was assessed by questionnaire.

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Organizational Data

  •   DRKS00009399
  •   2015/10/02
  •   [---]*
  •   yes
  •   Approved
  •   1566/06, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
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Interventions/Observational Groups

  •   24 IE Oxycotin intranasal
  •   Placebo intranasal
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   Yes
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Primary Outcome

Heart rate increase relative to baseline during listening to an individualized trauma script (assessed by impedance cardiography).

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Secondary Outcome

Subjective distress during listening to an individualized trauma script (Global scale 0-10) and Response to Script Driven Imagery Scale

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/11/18
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Prevalence of posttraumatic stress disorder

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Exclusion Criteria

Pregnancy, medication with beta-blockers, known cardiovascual diseases

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Addresses

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie, Klinikum rechts der Isar, Technische Universität München
    • Mr.  Prof. Dr. med.  Martin  Sack 
    • Langerstr. 3
    • 81675  München
    • Germany
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    start of 1:1-Block address contact scientific-contact
    •   089/4140-4312
    •   [---]*
    •   m.sack at tum.de
    •   [---]*
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    • Klinik für Psychosomatische Medizin und Psychotherapie, Klinikum rechts der Isar, Technische Universität München
    • Mr.  Prof. Dr. med.  Martin  Sack 
    • Langerstr. 3
    • 81675  München
    • Germany
    end of 1:1-Block address public-contact
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    •   089/4140-4312
    •   [---]*
    •   m.sack at tum.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Klinik für Psychosomatische Medizin und Psychotherapie, Klinikum rechts der Isar, Technische Universität München
    • Mr.  Prof. Dr. med.  Martin  Sack 
    • Langerst. 3
    • 81675  München
    • Germany
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    •   089/41404312
    •   [---]*
    •   m.sack at tum.de
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/10/31
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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.