Trial document




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  DRKS00003607

Trial Description

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Title

Psychiatric characterization of donors and recipicients of living donor liver transplantation - a prospective study

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The living donor liver transplantation is a psychological challenge for both donors and recipicients. In this study we evaluate the psychiatric consequences of this transplantation over a time span of 1 year. Psychiatric symptoms are assessed by psychometric tests.

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Brief Summary in Scientific Language

The LDLT has only been assessed by psychosomatic trials so far, concerning the question of motivation. A psychometric evaluation of both donors and recipicients should bring more information about psychosocial consequences of the LDLT. We assume that people with a premorbidly higher neuroticism scale shown a poorer adaptation to the transplantation. In this trial each 15 donors and recipicient are assessed with psychometric tests before, 3, 6 and 12 months after transplantation.

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Organizational Data

  •   DRKS00003607
  •   2012/03/15
  •   [---]*
  •   yes
  •   Approved
  •   297/11, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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

  •   patients with terminal liver dysfunction leading to necessity of transplantation
  •   Z94.4 -  Liver transplant status
  •   K72.9 -  Hepatic failure, unspecified
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Interventions/Observational Groups

  •   single arm study. Each donors and recipicients of living donor liver transplantation will be asekd by psychometric self rating questionnaires at four time points:
    Baseline (before transplantation): MMPI-2, CD-RISC, BDI, STAI, FLZ, SCL-90R.
    After 3, 6 , 12 Months (after transplantation): BDI, PTSS-10, STAI, FLZ, SCL-90R.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Primary end point of the study is the change of psychometric variables in terms of depression, anxiety and traumatic symptoms and life quality compared to the parameters in the baseline assessment. This will be measured in 3 follow up points:
3. month after transplantation: rating of depressive (BDI), posttraumatic (PTSS-10), anxiety (STAI) symptoms and general life quality (FLZ, SCL-90R).
6. month after transplantation: rating of depressive (BDI), posttraumatic (PTSS-10), anxiety (STAI) symptoms and general life quality (FLZ, SCL-90R).
12. month after transplantation: rating of depressive (BDI), posttraumatic (PTSS-10), anxiety (STAI) symptoms and general life quality (FLZ, SCL-90R).

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Secondary Outcome

not applicable.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/03/12
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

patients with terminal liver insufficiency which makes a liver transplantaion necessary

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Exclusion Criteria

cognitive deficits that prevent from understanding the psychometric tests.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychiatrie, Psychoatherapie und Psychosomatik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2016/10/30
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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.