Trial document




This trial has been registered retrospectively.
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  DRKS00008176

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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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.

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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.

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

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Description IPD sharing plan:

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Organizational Data

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

  •   F20 -  Schizophrenia
  •   F31 -  Bipolar affective disorder
  •   F33 -  Recurrent depressive disorder
  •   F84 -  Pervasive developmental disorders
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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
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/02/15
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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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:

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für seelische Gesundheit
    • Mr.  Prof. Dr. med.  Andreas  Meyer-Lindenberg 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für seelische Gesundheit
    • Dr.  Carolin  Mößnang 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für seelische Gesundheit
    • Dipl.psych.  Kristina  Otto 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Projektträger im DLR
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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    • GABO:milliarium mbH & Co. KG
    • Oskar-von-Miller Ring 29
    • 80333  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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