Trial document




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  DRKS00004761

Trial Description

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Title

Systems biology of Reelin-associated neuropsychiatric disorders

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Trial Acronym

ReelinSys

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URL of the Trial

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Brief Summary in Lay Language

In this Study, we will analyse genetically variations of the reelin system, so called de novo mutations. The reelin protein is essential for brainstructure and learning (neuronal plasticity). There are many references that held reelin responsible for psychiatric disorders. To detect De novo mutations, we will compare parental DNA with the DNA of the patient. The DNA is mesured by means of exom sequencing. With this method we will detect nearly all of the protein coding human genes. If there is a mutation in the genome of a patient, that is not found in the parental gene, this mutation is called novel or de novo mutation. Finally we will discuss the pathomechanisms of this mutation in the reelin system relating to psychiatric disorders.

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Brief Summary in Scientific Language

The collectivity of all Exonsequences averages 1% of the human genome, but it contains nearly the total number of all protein coding genes. So the exom sequencing offers the possability to detect all relevant point mutations. One important analytical procedure is a method to detect de novo mutations. This de novo sequencing adduced many important mutations in some psychiatric diseases like schizophrenia or asperger autism. This procedure implies the sequencing of parental DNA for the comparison with DNA of the affected descendent (trio analysis). A differnt base sequence of the patient in an target gene - in this study the genes of the reelin system - suggests a causal pathogenetic mechanism. This results could be serve as a sample for the virtual reelin system, that will be modeled by another subproject, to detect the whole effect from the transcriptome to the proteome. In a last step we could serve this as a sample to generate a PCR sonde to detect spontaneous mutations of numerous patients. The Exonsequences will be stored digitally.

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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

  •   DRKS00004761
  •   2013/05/14
  •   [---]*
  •   yes
  •   Approved
  •   94/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1140-6153 
  •   [---]* 
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Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer disease
  •   F20.0 -  Paranoid schizophrenia
  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
  •   F31 -  Bipolar affective disorder
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Interventions/Observational Groups

  •   Exom Sequencing of the patients with aforesaid psychiatric disorders
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Characteristics

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

global sequencing of all Reelin associated genes and reestablish a gene databbase with intent to detect
- gene polymorphism of the reelin system in psychiatric patients
- de novo mutaions
- specific mutations, which were detected by the other subprojects

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Secondary Outcome

Evaluation of hippocampal declerative Memory, Amygdala associated fear conditioning, cortical synaptic excitability and the results of brain imaging

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2013/05/14
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1) The ICD-10 criteria must be fulfilled for following disorders
a) Schizophrenia, paranoid type
b) Major depression
c) bipolar affective Disorder
d) Alzheimer's Disease
2) There has to be a previous episode of the diseases a), b), c)
3) The minimum age presupposed 18 years (legal age)

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Exclusion Criteria

1) Axis II Disorder
2) Axis I Co- Morbidity
3) Chronical Progress
4) Maximum age presupposed 65 years for the diseases a), b), c)

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Addresses

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    • Abtl. Psychiatrie und Psychotherapie, Universitätsklinikum Freiburg
    • Mr.  PD Dr. med.  Claus  Normann 
    • Hauptstr. 6
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
    • Mr.  PD Dr.  Claus  Normann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
    • Mr.  Dr. med  Tobias  Hornig 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF)
    • Heinemannstr. 2
    • 53173  Bonn
    • Germany
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    •   +49 228 9957-0
    •   +49 228 9957-83601
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    •   http://www.bmbf.de
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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