Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00008176

Trial Description

start of 1:1-Block title

Title

Neural and molecular risk mechanisms of autism, affective disorders and psychoses.

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

The current project aims to 1) enlarge available datasets of healthy controls and first-degree relatives of patients with schizophrenia, bipolar disorder and depression, and 2) collect structural und functional neuroimaging data of patients suffering from these disorders. In addition this established approach will be transferred to autistic spectrum disorder (ASD) and phenotypes concerning social cognition will be collected in addition. Therefore data of patients with ASD and first degree relatives are going to extend current datasets. By applying innovative statistical methods, we aim to identify diagnostic and transdiagnostic neurocognitive markers, as well as their genetic background.

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

Brief Summary in Scientific Language

The present project will apply an innovative neuroimaging approach, which is based on previous work conducted within the context of the MooDS Consortium. This previous work involved the investigation of psychiatric genetic risk factors in healthy controls and healthy first-degree relatives of patients with psychosis and affective disorders. This project will extend this work to patients with schizophrenia (SCZ), bipolar disorder (BD) and major depression (MD). In addition patients with autism spectrum disorder (ASD) and first degree relatives of patients with ASD will be examined. We will use neuroimaging paradigms established and validated in MooDS and EU-AIMS and apply new and innovative computational methods of analysis in order to discover dimensional neural markers across currently used diagnostic boundaries. We will then correlate these markers with the extended clinical and biological phenotypes of the investigated patients. The goals of this project are therefore to: (1) identify and validate integrative (i.e. imaging, genetics, clinical, environmental) markers for the differential diagnosis of SCZ, BD, MD and ASD; and (2) validate the application of these markers for the prediction of treatment-response, relapse, and side effect development in medicated and un-medicated patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008176
  •   2015/06/29
  •   [---]*
  •   yes
  •   Approved
  •   2014-637N-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

  •   F20 -  Schizophrenia
  •   F31 -  Bipolar affective disorder
  •   F33 -  Recurrent depressive disorder
  •   F84 -  Pervasive developmental disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   1. Patients:

    • Study content: The study contains standardized and half standardized interviews to confirm the existences and further characterization of the psychiatric disorder. Furthermore a broad battery of questionnaires to access general personality traits and a neuropsychological test battery to characterize the cognitive performance level are assessed. To do genetic analyses a blood sample is taken. The MRI assessment includes a battery of structural and functional sequences.
    • Gruppen
    - Patienten mit schizophrener Psychose
    - Patienten mit bipolarer Störung
    - Patienten mit unipolarer Depression
    - Patienten mit Autismus
  •   2. Angehörige
    • Study content: The study contains a screening interview to access the existence of possible psychiatric disorders. Furthermore a broad battery of questionnaires to access general personality traits and a neuropsychological test battery to characterize the cognitive performance level are assessed. To do genetic analyses a blood sample is taken. The MRI assessment includes a battery of structural and functional sequences.
    • Gruppen
    - Angehörige mit schizophrener Psychose
    - Angehörige mit bipolarer Störung
    - Angehörige mit unipolarer Depression
    - Angehörige mit Autismus
  •   3. Gesunde Probanden
    • Study content: The study contains a screening interview to access the existence of possible psychiatric disorders. Furthermore a broad battery of questionnaires to access general personality traits and a neuropsychological test battery to characterize the cognitive performance level are assessed. To do genetic analyses a blood sample is taken. The MRI assessment includes a battery of structural and functional sequences
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Identification of multivariate neurocognitive markers, that allow the transdiagnostic classification of patient subgroups according to biological criteria

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

Secondary Outcome

Find evidence for genetic contributions to disorder-specific and transdiagnostic neurocognitve markers.

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

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

Recruitment

  •   Actual
  •   2015/02/15
  •   500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Additional Inclusion Critera:
- all subjects:
o Sufficient german language abilities
o Ability to understand study protocol and give written informed consent
- For healthy controls
o No diagnosis of any psychiatric disorder according to ICD-10 and DSM-IV
o No family history of any psychiatric disorder according to ICD-10 and DSM-IV
- For first grade relatives:
o First grade relative with the diagnosis of ASD, SZ, BP or MD according to ICD-10 or DSM-IV
- For patients:
o Diagnosis of ASD, SZ, BP or MD according to ICD-10 or DSM-IV
Exclusion Criteria:

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

Exclusion Criteria

Exclusion Criteria:
- For women: pregnancy
- MR exclusion criteria (metal implants, brain surgery, permanent makeup)
- Current alcohol or drug abuse
- For healthy controls and first degree relatives: psychiatric disorder according to ICD-10 or DSM-IV

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
    • Mr.  Prof. Dr. med.  Andreas  Meyer-Lindenberg 
    • 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
    • Dr.  Carolin  Mößnang 
    • 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
    • Dipl.psych.  Kristina  Otto 
    • 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
    • Projektträger im DLR
    • Heinrich-Konen-Straße 1
    • 53227  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
  • start of 1:1-Block address otherSupport
    • GABO:milliarium mbH & Co. KG
    • Oskar-von-Miller Ring 29
    • 80333  München
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.