Trial document




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  DRKS00009820

Trial Description

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Title

Validating genomic biomarkers as risk markers for incidence, non-response and recurrence in depression - EDSP Study

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Trial Acronym

OptiMD-SP4 EpiFam

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URL of the Trial

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Brief Summary in Lay Language

Preliminary own work and findings of our partners point to a special significance of the blood-brain barrier gene ABCB1, the stress regulation gene FKBP5 and so-called "Gliotransmitter" genes P2RX4 and P2RX7 with respect to depression risk and antidepressant treatment outcome. Genomic indicators of the activity of these genes and their epigenetic modifications are promising candidates for serving as genomic biomarkers of depression, which will be validated in this program. There are three subprojects. The subproject considere here is called EDSP study aiming to ilucidate the role of epigenetic biomarkers in regard to the inheritance of a disease risk for depression. A family study with 100 children and adolescents will be carried out, half of them with a mother suffering from depression (cases), while the parents of the other half will be negative for mental disorders (controls). Saliva samples will be collected from children and parents to obtain DNA. In addition, chemical modifications of the DNA (so-called epigenetic modifications) will be measured that can be inherited from parents to children likewise DNA and thus can contribute to the inheritance of the disease risk. We expect that the disease risk is relfected by a higher similarity of epigenetic modifications between child and parents from families with maternal depression diagnosis. The aim of subproject is to identify these modifications and to determine their contribution to the disease risk.

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Brief Summary in Scientific Language

We will perfrom a family study involving 100 children and adolescents from families with and without maternal lifetime diagnosis of depression to investigate the role of epigenetic DNA modifications for the inheritance of depression risk. Diagnostic tests in children will be performed using the Diagnostic Interview for Mental Disorders in Children and Adolescents (Kinder-DIPS), in parents using the Munich Composite Internation Diagnostic Interview for Mental Disorders (M-CIDI). Saliva samples will be collected among children and parents, from which DNA will be extracted and genoytyped; further, methylation rate in CpG-rich gene regions will be examined. In particular, the following candidate genes at the center of analysis: ABCB1, FKBP5, P2RX4, P2RX5. Genetically and epigenetically inherited information will be compared between case and control families.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009820
  •   2016/12/14
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  •   yes
  •   Approved
  •   623-16, 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

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Family study investigating the inheritance of epigenetic modifications (DNA methylation) in CpG-rich regions within candidate genes (ABCB1, FKBP5, P2RX4, P2RX5) between children and adolescents from families with and without
    maternal lifetime diagnosis of depression.
    Saliva samples will be collected among children and parents, from which DNA will be extracted and genoytyped; further, methylation rate in CpG-rich gene regions will be examined. Genetically and epigenetically inherited information will be compared between case and control families.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Association of methylation rates between child and mother or father separately for families with and without maternal depression. The objective is to identify those genetic loci that allow the strongest separation of both groups of families. The analysis is focussed on DNA methylation in CpG-rich regions of the genes ABCB1, FKBP5, P2RX4 and P2RX7.

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Secondary Outcome

Allelci transmission rates of the candidate genes ABCB1, FKBP5, P2RX4 and P2RX7 from parents to child separately for families with and without maternal depression.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/12/08
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   17   Years
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Additional Inclusion Criteria

Children and adolescents of both sexes aged 3 to 17 years, balanced in age and sex distribution between cases and controls; study consent of at least one parent or guardian of the study participant as well as oral and / or written consent of the minor study participant.

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Exclusion Criteria

Pervasive developmental disorder in study participants (ICD10 F84)

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Addresses

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    • Max-Planck-Institut für Psychiatrie
    • Ms.  MD, PhD  Elisabeth  Binder 
    • Kraepelinstr. 2-10
    • 80804  München
    • Germany
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    • Max-Planck-Institut für Psychiatrie
    • Mr.  Dr.  Marcus  Ising 
    • Kraepelinstr. 2-10
    • 80804  München
    • Germany
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    • Max-Planck-Institut für Psychiatrie
    • Mr.  Dr.  Marcus  Ising 
    • Kraepelinstr. 2-10
    • 80804  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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