Trial document




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  DRKS00007110

Trial Description

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Title

Pilotstudy on oxytocin and social-coggnitive functions in schizophrenia patients with vs. without a history of violence compared to healthy control subjects

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Trial Acronym

Oxy1

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This is a medical, basic science, non-pharmacological study on schizophrenia subjects with vs. without a history of violence compared to healthy controls. Using blood and saliva samples we measure peripheral oxytocin levels. In parallel, we assess social-cognitive functions. The main hypothesis of our study is that schizophrenia subjects with a history of violence may have socila-cognitive deficits correlating with peripheral oxytocin levels.

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Brief Summary in Scientific Language

This is a medical, basic science, non-pharmacological study on schizophrenia subjects with vs. without a history of committing violence compared to healthy controls. Using blood and saliva samples we measure peripheral oxytocin levels. In parallel, we assess social-cognitive functions. The main hypothesis of our study is that schizophrenia subjects with a history of violence may have social-cognitive deficits correlating with peripheral oxytocin levels.

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Organizational Data

  •   DRKS00007110
  •   2014/11/04
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  •   yes
  •   Approved
  •   4758, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   Healthy Controls
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Interventions/Observational Groups

  •   schizophrenia and history of violence: Assessments of baseline oxytocin, oxytocin response to emtional stimulus, performance in affect recognition and empathy
  •   schizophrenia without history of violence: Assessments of baseline oxytocin, oxytocin response to emtional stimulus, performance in affect recognition and empathy
  •   healthy without history of violence: Assessments of baseline oxytocin, oxytocin response to emtional stimulus, performance in affect recognition and empathy
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

basline oxytocin level in blood plasma and saliva measured by HPLC

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Secondary Outcome

oxytocin response measured in blood plasm by HPLC before and after an emotional stimulus, concurrent standardized psychometric measurment of performance in affect recognition and empathy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/12/01
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

dignosis of schizophrenia or schizophrenia spectrum disorder (ICD-10: F2x)

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Exclusion Criteria

intellectual disability, language barrier, primary diagnosis of addiction, primary diagnosis of neurological disorder, wasting disorder

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Addresses

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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der Heinrich-Heine-Universität, Düsseldorf
    • Mr.  Prof. Dr. med.  Wolfgang  Gaebel 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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    • LVR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Mr.  PD Dr.  Christian  Luckhaus 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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    • LVR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Mr.  PD Dr. med.  Christian  Luckhaus 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der Heinrich-Heine-Universität
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • 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.