Trial document




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  DRKS00008932

Trial Description

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Title

PsYchoTHerapy - Intergenerational Actions

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Trial Acronym

PYTHIA

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URL of the Trial

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Brief Summary in Lay Language

The DNA contains the genetic code, e.g. the genetic information. Through several mechanisms - independent of the gen code - the probability of using specific genes can be modulated. Multiple environmental factors act on these "epigenetic" mechanisms.
Our study tests the hypothesis that psychotherapy of chronic depression has impact on these mechanisms. Therefore, male patients with chronic depression will be investigated before and after psychotherapy. We will study blood, saliva and sperm. Thereby, we test whether psychotherapy has effects on the "epigenetic programing" of the individual and whether there are potential effects on the next generation.

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Brief Summary in Scientific Language

We test the effect of CBASP (Cognitive Behavioral Analysis System of Psychotherapy) psychotherapy of chronic depression on epigenetic regulation. We will study lymphocytes, saliva and sperm. Thereby, we can test the hypothesis that successful psychotherapy impacts on epigenetic regulation of the individual patient as well as, potentially, his offspring. We will study extreme groups of patients with good vs. bad outcome of psychotherapy. In parallel, we will study healthy controls.
Lab method: Infinium HumanMethylation450 BeadChip; Time points of measures: before therapy (blood, saliva, sperm), end of psychotherapy (blood, saliva), 8 weeks after end of psychotherapy (blood, saliva, sperm)

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Organizational Data

  •   DRKS00008932
  •   2015/07/27
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  •   yes
  •   Approved
  •   2015-564N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F34 -  Persistent mood [affective] disorders
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Interventions/Observational Groups

  •   chronically depressed patients with good clinical response to CBASP psychotherapy (10 weeks of inpatient psychotherapy, twice 90 minutes group psychotherapy per week, once 45 minutes individual psychotherapy per week)
    Examination of DNA methylation before therapy (blood, saliva, sperm), end of psychotherapy (blood, saliva), 8 weeks after end of psychotherapy (blood, saliva, sperm)
  •   chronically depressed patients without good clinical response to CBASP psychotherapy (10 weeks of inpatient psychotherapy, twice 90 minutes group psychotherapy per week, once 45 minutes individual psychotherapy per week)
    Examination of DNA methylation before therapy (blood, saliva, sperm), end of psychotherapy (blood, saliva), 8 weeks after end of psychotherapy (blood, saliva, sperm)
  •   healthy controls
    Examination of DNA methylation (blood, saliva, sperm)
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Characteristics

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

clinical response to psychotherapy as measured by standard instruments (before and after therapy: CGI; weekly: MADRS);
DNA methylation: Lab method: Infinium HumanMethylation450 BeadChip; Time points of measures: before therapy (blood, saliva, sperm), end of psychotherapy (blood, saliva), 8 weeks after end of psychotherapy (blood, saliva, sperm)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/08/15
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

chronic depression with early onset, clinical indication for CBASP, male, 18 - 65 years, german language skills, ability to consent; for healthy controls: exclusion of mood disorders

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Exclusion Criteria

evidence for organic affective disorder, bipolar I affective disorder or schizophrenia; evidence for major urologic disorder; polypharmacy; use of steroid hormones

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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