Trial document




This trial has been registered retrospectively.
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  DRKS00009819

Trial Description

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Title

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

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Trial Acronym

OptiMD-SP4 CAP

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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 considered here is called CAP study aiming to validate epigenetic biomarkers in regard to the risk of developing depression. A case/control study with 100 adolescents will be carried out, half of them suffering from depression (cases), while the other half will be negative for psychiatric disorders (controls). Saliva samples will be collected from both groups to obtain DNA. In addition, chemical modifications of the DNA (so-called epigenetic modifications) will be measured, which, unlike DNA, can be affected by environmental conditions and thereby might additionally contribute to the disease risk. We expect that both, genetic variations and epigenetic DNA modifications ciontribute to the disease risk. The aim of subproject is to identify those characteristics and to determine their contribution to the disease risk.

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Brief Summary in Scientific Language

To validate epigenetic biomarkers for the disease risk of depression we are recruiting 50 adolescents with and 50 adolescents without diagnosis of acute depression for a case/control study. Clinical diagnosis will be optained using the Diagnostic Interview for Mental Disorders in Children and Adolescents (Kinder-DIPS). DNA will be extracted from saliva samples, genotyped and methylation rates of CpG-rich regions will be analyzed and compared between cases and controls. In particular, methylation rates of the following candidate genes are in the center of the analysis: ABCB1, FKBP5, P2RX4, P2RX5.

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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

  •   DRKS00009819
  •   2016/01/13
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  •   yes
  •   Approved
  •   419-15, 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

  •   Case/Control study comparing epigenetic modifications (DNA methylation) in CpG-rich regions within candidate genes (ABCB1, FKBP5, P2RX4, P2RX5) between adolescents with and without diagnosis of major depression.
    DNA will be extracted from saliva samples, genotyped and methylation rates of CpG-rich regions will be analyzed and compared between cases and controls.
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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

Case or control group assignment based on a detailed diagnosis using the Diagnostic Interview for Mental Disorders in Children and Adolescents (Kinder-DIPS). Genetic variations and DNA methylation rates in CpG-rich regions of the genes ABCB1, FKBP5, P2RX4 and P2RX7 will be determined as predictors of the case/control status.

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Secondary Outcome

N.A.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Children and adolescents of both sexes aged 8 to 18 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

  • start of 1:1-Block address primary-sponsor
    • Max-Planck-Institut für Psychiatrie
    • Mr.  Dr.  Marcus  Ising 
    • Kraepelinstr. 2-10
    • 80804  München
    • Germany
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    • Klinikum der UniversitätInstitut für Kinder- und Jugendpsychiatrie
    • Mr.  Prof. Dr.  Gerd  Schulte-Körne 
    • Nußbaumstr. 5a
    • 80337  München
    • Germany
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    • Klinikum der UniversitätInstitut für Kinder- und Jugendpsychiatrie
    • Mr.  Prof. Dr.  Gerd  Schulte-Körne 
    • Nußbaumstr. 5a
    • 80337  München
    • Germany
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    • Klinikum der UniversitätInstitut für Kinder- und Jugendpsychiatrie
    • Mr.  Prof. Dr.  Gerd  Schulte-Körne 
    • Nußbaumstr. 5a
    • 80337  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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* This entry means the parameter is not applicable or has not been set.