Trial document




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  DRKS00016359

Trial Description

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Title

Exploring the long-term impact of early life adversity on the (anti-)social brain

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Trial Acronym

MARS T11

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URL of the Trial

https://www.zi-mannheim.de/forschung/personen/person-projekte/person-projekte/5207.html

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Brief Summary in Lay Language

The investigation of the effects of early adversity and protective factors on the social brain might significantly enhance our understanding of the etiology of antisocial psychiatric disorders.
The study will examine how stress during development impacts on brain structure and function with the latter being assessed via magnetic resonance imaging. Likewise, it will be investigated how protective factors, aquired in a smarthone-based real-life assessment, might counteract the effect of early adversity in participants from an epidemiological cohort followed since birth.

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Brief Summary in Scientific Language

Although the study of environmental adversity promises to provide important clues about individual variation in the etiology of complex psychiatric disorders, conclusive pathways to brain endophenotypes of social and antisocial behavior are largely missing. Likewise, it is still unclear how protective factors including social interactions, sociodemography and physical activity impact on that relationship. A combination of research of the long-term effects of early environmental adversity and protective factors with neuroimaging may provide a powerful strategy. In the proposed project, we aim to study the impact of environmental adversities during early development and lifetime protective factors on neural networks implicated in social behavior, as assessed by structural MRI and functional MRI. 280 young adults (both healthy and with current psychopathology) from an epidemiological cohort study followed since birth will be assessed. In detail, neural circuitries will be examined encompassing different dimensions of social behavior, such as social interaction, social cognition, modulation of social behavior and motivation. Candidate environmental conditions with sizeable and established effects on brain function and structure in this sample, covering prenatal and early postnatal adversities, will be investigated. The identification of neural mechanisms underlying the effects of early adversity and protective factors on neural networks implicated in social behavior, and their stability over time, will help to establish more effective ways of diagnosing, preventing and treating mental disorders, especially those involved in antisocial behavior.

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Organizational Data

  •   DRKS00016359
  •   2019/01/17
  •   [---]*
  •   yes
  •   Approved
  •   2015-612N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Vulnerability to stress-related antisocial disorders
  •   F91 -  Conduct disorders
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Interventions/Observational Groups

  •   The investigation will be performed in participants from the Mannheim Study of Children at Risk. The MARS is prospective longitudinal study of an epidemiological cohort followed since birth. For the 32-year assessment, n=309 participants will be available for diagnostic interview (SCID) and out of these a subsample will be additionally recruited n=280 for functional imaging (MRI) and smartphone-based assessment.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Effects of early adversity and protective factors on brain morphology and function implicated in the processing of social information. Specifically, we will investigate: 1) real-life quantitz and quality of social interactions via smartphone, 2) brain volume, surface area and cortical thickness, 3) BOLD response during the following tasks: empathy, emotion regulation, stop signal, reward, passive avoidance, cyberball and dictator game.

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Secondary Outcome

not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/01/16
  •   280
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   32   Years
  •   35   Years
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Additional Inclusion Criteria

participants of the Mannheim Study of Children at Risk

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Exclusion Criteria

metal implants or other MRI contraindications

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Addresses

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    • Zentralinstitut für seelische Gesundheit
    • J5
    • 68167  Mannheim
    • Germany
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    • ZI
    • Ms.  Dr.  Nathalie  Holz 
    • J5
    • 68167  Mannheim
    • Germany
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    • ZI
    • Ms.  Dr.  Nathalie  Holz 
    • J5
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 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.