Trial document
This trial has been registered retrospectively.
DRKS00009819
Trial Description
Title
Validating genomic biomarkers as risk markers for incidence, non-response and recurrence in depression - CAP Study
Trial Acronym
OptiMD-SP4 CAP
URL of the Trial
[---]*
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00009819
- 2016/01/13
- [---]*
- yes
- Approved
- 419-15, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
Secondary IDs
- [---]*
Health Condition or Problem studied
- F32 - Depressive episode
- F33 - Recurrent depressive disorder
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.
Characteristics
- Non-interventional
- Other
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Diagnostic
- Single (group)
- N/A
- N/A
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.
Secondary Outcome
N.A.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2015/09/01
- 100
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 8 Years
- 18 Years
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.
Exclusion Criteria
Pervasive developmental disorder in study participants (ICD10 F84)
Addresses
-
start of 1:1-Block address primary-sponsor
- Max-Planck-Institut für Psychiatrie
- Mr. Dr. Marcus Ising
- Kraepelinstr. 2-10
- 80804 München
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- ising at psych.mpg.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Klinikum der UniversitätInstitut für Kinder- und Jugendpsychiatrie
- Mr. Prof. Dr. Gerd Schulte-Körne
- Nußbaumstr. 5a
- 80337 München
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Klinikum der UniversitätInstitut für Kinder- und Jugendpsychiatrie
- Mr. Prof. Dr. Gerd Schulte-Körne
- Nußbaumstr. 5a
- 80337 München
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 089 5160-5901
- [---]*
- Gerd.Schulte-Koerne at med.uni-muenchen.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinikum der UniversitätInstitut für Kinder- und Jugendpsychiatrie
- Mr. Prof. Dr. Gerd Schulte-Körne
- Nußbaumstr. 5a
- 80337 München
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 089 5160-5901
- [---]*
- Gerd.Schulte-Koerne at med.uni-muenchen.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung Dienstsitz Bonn
- Heinemannstr. 2
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.bmbf.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*