Trial document





This trial has been registered retrospectively.
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  DRKS00005801

Trial Description

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Title

Integrated understanding of causes and mechanisms in mental disorders: Transdiagnostic neurocognitive biomarkers

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Trial Acronym

IntegraMent_MRI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In addition to available data of healthy controls and first-degree relatives of patients with schizophrenia, bipolar disorder and depression, we will collect structural und functional neuroimaging data of patients suffering from these disorders. 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). We will use neuroimaging paradigms established and validated in MooDS 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, and MD;
and (2) validate the application of these markers for the prediction of treatment-response, relapse, and side effect development in medicated and unmedicated patients.

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Organizational Data

  •   DRKS00005801
  •   2014/10/29
  •   [---]*
  •   yes
  •   Approved
  •   2011-254N-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

  •   Schizophrenia, bipolar disorder and major depression
  •   F20 -  Schizophrenia
  •   F31 -  Bipolar affective disorder
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   1. Patients with schizophrenia: MR-Scan, Blood sample for genetyping, clinical evaluation, extended neuropsychological tests, questionaires to assess psychological variables as well as environmental risk factors.

  •   2. Patients with bipolar disorder: MR-Scan, Blood sample for genetyping, clinical evaluation, extended neuropsychological tests, questionaires to assess psychological variables as well as environmental risk factors.


  •   3. Patients with major depression: MR-Scan, Blood sample for genetyping, clinical evaluation, extended neuropsychological tests, questionaires to assess psychological variables as well as environmental risk factors.

  •   4. Patient with ultra-high risk for psychosis: MR-Scan, Blood sample for genetyping, clinical evaluation, extended neuropsychological tests, questionaires to assess psychological variables as well as environmental risk factors.

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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
  •   Other
  •   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

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/05/08
  •   220
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- Ability to understand study protocol and give written informed consent

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Exclusion Criteria

- MR exclusion criteria (metal implants, brain surgery, permanent makeup)
- Current alcohol or drug abuse

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Addresses

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    • Zentrales Institut für seelische Gesundheit, Abteilung Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. med.  Andreas  Meyer-Lindenberg 
    • J5
    • 68159  Mannheim
    • Germany
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    • Universitätsmedizin Berlin, Campus Charité MitteAbteilung für Psychiatrie und Psychotherapie
    • Mr.  Prof.Dr.med  Andreas  Heinz 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Zentrales Institut für Seelische GesundheitAbteilung Psychatrie und Psychotherapie
    • Mr.  Prof.Dr.med.  Andreas  Meyer-Lindenberg 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentrales Institut für seelische Gesundheit, Abteilung Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. med.   Andreas  Meyer-Lindenberg 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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