Trial Description

DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
Epigenetic effects of exposure to pre-, peri- and postnatal stress assessed in early
infancy (subproject 1 of "Prä-, peri- und pOstnatal Stress in human and non-human
offspring: Epigenetic Impact on DepressiON (POSEIDON)") / DIAbetes Mellitus Obstetric and Neonatal Distress: Epigenetic Effects (DiaMOND E2)
Trial Acronym
POSEIDON / DiaMOND E2
URL of the trial
[---]*
Brief Summary in Lay Language
We will characterize a group of 400 mothers and their infants with regard to stress
before and after birth and sample umbilical cord blood and oral mucosal swabs in
order to analyze DNA methylation, which is considered a modification of DNA due
to environmental factors that could predispose the off-spring to adult disease,
especially depression or diabetes mellitus. We will test whether and, potentially,
what early life stressors may be associated with methylation of genes that are
involved in the pathophysiology of depression or diabetes mellitus
Brief Summary in Scientific Language
Our consortium aims at characterizing a cohort sample of 400 mothers and their
infants with regard to pre-, peri- and postpartal stress and sampling umbilical cord
blood, oral mucosal swabs, placenta tissue at birth and 6 months postpartum for
analysis of DNA methylation. We will analyze candidate genes for depression and
do genome-wide methylation studies in extreme groups with respect to early life
stress in humans. The assessment of epigenetic modifications during early infancy
will prevent later environmental factors to confound the tracks of early
enviromental influences on the epigenonme. Not only the effects of adverse
environment and early life stress, but also of potentially protective environments
will be examined.
Organizational Data
DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Page 1 of 6
DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 2010-309N-MA , Medizinische Ethik-Kommission II
Medizinische Fakultät Mannheim der Universität Heidelberg
Secondary IDs
Health condition or Problem studied
ICD10: F32 - Depressive episode
ICD10: E11 - Non-insulin-dependent diabetes mellitus
Interventions/Observational Groups
Arm 1: Early life stress will be charakterized by history, questionnaires, saliva
cortisol (mothers) and cortisol in diaper urine. We will use the following
instruments:
Perceived Stress Scale, Munich Events List, Social Support Questionnaire,
Physical Health Checklist, SCID-I (Mutter), Edinburgh Postnatal Depression
Scale, Prenatal Attachment Scale, Parenting Stress Index, Postpartum Bonding
Questionnaire, Questionnaire on Maternal Attitudes towards Infants,
Breastfeeding Questionnaire, Infant Behavior Questionnaire, Liefe Experience
Questionnaire, Postpartum Bonding Questionnaire, Mother-child interaction
(video analysis)
We will use 3 time points of investigation: 3. trimenon, birth, 6 months pp
Characteristics
Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
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DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Basic research/physiological study
Assignment: Single (group)
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A
Primary Outcome
As outcome variables, we will investigate genome-wide methylation patterns (cord
blood at birth) in extreme groups and their changes during early infancy (buccal
mucosa swab at birth and 6 months).
Secondary Outcome
Methylation of promoters of candidate genes for depression and diabetes and
their change during course of observation (birth, 6 months postpartal).
Countries of recruitment
DE Germany
Locations of Recruitment
University Medical Center University of Heidelberg, dept. of gynecology and dept.
of obstetrics, Heidelberg
Medical Center St. Marien hospital, Ludwigshafen am Rhein
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2011/03/30
Target Sample Size: 400
Monocenter/Multicenter trial: Multicenter trial
National/International: National
Page 3 of 6
DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Inclusion Criteria
Gender: Female
Minimum Age: 16 Years
Maximum Age: no maximum age
Additional Inclusion Criteria
mother = main caregiver, German-speaking, no severe physical disease, no
psychiatric disorder requiring inpatient treatment, birth weight > 1500 gr,
gestational age > 32 weeks, AGPAR > 7
Exclusion criteria
twin birth, major birth trauma of child or other major handicap
Addresses
Primary Sponsor
Zentralinstitut für Seelische Gesundheit
Mr. Prof. (apl) Dr. med. Michael Deuschle
J5
68159 Mannheim
Germany
Telephone: 0621 1703 2331
Fax: 0621 1703 2325
E-mail: michael.deuschle at zi-mannheim.de
URL: [---]*
Contact for Scientific Queries
Zentralinstitut für Seelische Gesundheit
Mr. Prof. (apl) Dr. med. Michael Deuschle
J5
68159 Mannheim
Germany
Telephone: +049 621 1703 2331
Fax: +049 621 1703 2325
E-mail: michael.deuschle at zi-mannheim.de
URL: [---]*
Contact for Public Queries
Zentralinstitut für Seelische Gesundheit
Mr. Prof. (apl) Dr. med. Michael Deuschle
Page 4 of 6
DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Contact for Public Queries
Zentralinstitut für Seelische Gesundheit
Mr. Prof. (apl) Dr. med. Michael Deuschle
J5
68159 Mannheim
Germany
Telephone: 0621 1703 2331
Fax: 0621 1703 2325
E-mail: michael.deuschle at zi-mannheim.de
URL: [---]*
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body
(German Research Foundation (DFG), Federal Ministry of Education and
Research (BMBF), etc.)
Bundesministerium für Bildung und Forschung (ERANET NEURON)
53175 Bonn
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Private sponsorship (foundations, study societies, etc.)
Dietmar Hopp Stiftung
68789 St. Leon-Rot
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
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DRKS-ID: DRKS00003600
Date of Registration in DRKS: 2012/03/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
* This entry means the parameter is not applicable or has not been set.
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