Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003604

Trial Description

start of 1:1-Block title

Title

Neural correlates of stress-related gene-environment interactions

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Although the study of the interplay between genes and environment (GxE) promises to provide important clues as to the causes of complex disorders, current evidence of GxE in psychiatry remains inconclusive. In order to fulfill its potential, an integration of GxE research with the field of neuroscience may provide a powerful strategy. In the proposed project, we aim to study the joint effects of genes and environment on neural networks that are particularly sensitive to stress. Participants in this study are young adult members of a longitudinal study followed since birth. Using magnetic resonance imaging and electroencephalography, the structure and function of brain regions involved in emotional and motivational processing are investigated. Identification of mechanisms underlying GxE in stress-sensitive neural networks will help to provide a better understanding of the causes of increased vulnerability to stress-related disorders, such as depression and alcohol dependence.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of the present investigation is to improve our understanding of the neural substrates and mechanisms underlying gene-environment interaction (GxE) with regard to stress-related disorders, such as depression, posttraumatic stress disorder, and alcohol dependence. In the proposed projekt,
we intend to examine the joint influence of variation in candidate genes and candidate environmental conditions on the structure, function and connectivity of neural circuits particularly sensitive to stress. In 200 young adults from an epidemiological cohort study followed since birth, MRI and fMRI combined with EEG will be performed to assess the morphology and function of brain regions involved in emotion regulation and reward processing. As candidate genes, functional variants implicated in serotonin and dopamine signaling will be examined. As candidate environmental conditions, prenatal adversities will be contrasted with early postnatal and adolescent life adversities. Identification of mechanisms underlying GxE in stress-sensitive neural networks will help to establish more effective ways of diagnosing, preventing and treating stress-related disorders.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003604
  •   2012/03/12
  •   [---]*
  •   yes
  •   Approved
  •   2010-236N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   vulnerability for stress-related psychiatric disorders, such as depression, posttraumatic stress disorder, alcohol dependence
  •   F32.9 -  Depressive episode, unspecified
  •   F43.1 -  Post-traumatic stress disorder
  •   F10 -  Mental and behavioural disorders due to use of alcohol
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The investigation will be conducted using members of the Mannheim Study of Children at Risk (MARS), an epidemiological cohort study following a sample of 384 children at risk of later psychopathology from birth into adulthood. For the assessment at age 24-26, a sample of N=312 (150 males, 162 females) is available. From these, N=200 members of the main study will be selected according to defined criteria who will participate in a neuroimaging (MRI, DTI, fMRI) assessment.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

effects of genes and environmental adversity on the structure, function and connectivity of neural circuits involved in emotion regulation and reward processing. In detail, the following assessments will be conducted: (i) structural neuroimaging (voxel-based morphometry), (ii) diffusion tensor imaging (DTI), and (iii) functional neuroimaging using three experimental paradigms to assess BOLD fMRI combined with EEG response during the execution of an emotional arousal (face matching) task, a response conflict and inhibition (flanker) task, and a reward task (differential conditioning paradigm).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/03/11
  •   312
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   24   Years
  •   26   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Current participants of the Mannheim Study of Children at Risk

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Participants in the main study: current psychiatric disorder, psychiatric treatment, drug or alcohol abuse, neurological disorder and other serious medical conditions, left-handedness, metallic implants

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters
    • Mr.  Prof. Dr.   Manfred  Laucht 
    • J5
    • 68159  Mannheim
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters
    • Mr.  Prof. Dr.  Daniel  Brandeis 
    • J5
    • 68159  Mannheim
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters
    • Ms.  Sibylle  Heinzel 
    • J5
    • 68159  Mannheim
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/05/27
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Holz, N., Buchmann, A.F., Boecker, R., Blomeyer, D., Baumeister, S., Wolf, I., Rietschel, M., Witt, S.H., Plichta, M., Meyer-Lindenberg, A., Banaschewski, T., Brandeis, D., Laucht, M. (2014). Role of FKBP5 in emotion processing: Results on amygdala activity and connectivity. Brain Structure and Function, DOI 10.1007/s00429-014-0729-5.
  •   Holz, N., Boecker, R., Baumeister, S., Hohm, E., Zohsel, K., Buchmann, A.F., Blomeyer, D., Jennen-Steinmetz, C., Hohmann, S., Wolf, I., Plichta, M., Meyer-Lindenberg, A., Banaschewski, T., Brandeis, D., Laucht, M. (2014). Impact of prenatal tobacco smoke exposure on inhibitory control: neuroimaging results from a prospective study over 25 years. JAMA Psychiatry, 71, 786-96.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.