Trial document




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  DRKS00008321

Trial Description

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Title

In vivo quantification of the sigma1-receptor availability by means of Positron Emission Tomography (PET) in depressed subjects and healthy controls

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Trial Acronym

Sigma-PET

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Assessment of the sigma1-receptor status in depressed subjects and
healthy controls

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Brief Summary in Scientific Language

Aim of the study is to evaluate the sensitivity and specifity of (-)-[18F]Fluspidine-PET first in human to discriminate between depressed patients and healthy controls of equal age and gender.

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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

  •   DRKS00008321
  •   2015/05/06
  •   [---]*
  •   yes
  •   Approved
  •   254/11, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   2014-005427-27 
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Health Condition or Problem studied

  •   F34.1 -  Dysthymia
  •   F31.3 -  Bipolar affective disorder, current episode mild or moderate depression
  •   F31.4 -  Bipolar affective disorder, current episode severe depression without psychotic symptoms
  •   F31.5 -  Bipolar affective disorder, current episode severe depression with psychotic symptoms
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   patients with major depression, visit 1: PET scan of 120 minutes duration with (-)-[18F]Fluspidine (300 +/- 10% MBq) splitted in 2 scans of 90 respectively 30 minutes within one day.
    visit 2: safety follow up: physical examination, adverse events, vital signs (heart rate, blood pressure), ECG, blood parameters, urin status
  •   healthy controls corresponding to patients with major depression, visit 1: PET scan of 120 minutes duration with (-)-[18F]Fluspidine (300 +/- 10% MBq) splitted in 2 scans of 90 respectively 30 minutes within one day.
    visit 2: safety follow up: physical examination, adverse events, vital signs (heart rate, blood pressure), ECG, blood parameters, urin status
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   0
  •   No
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Primary Outcome

Examination of the central sigma-1-receptor availibility in patients with major depressive disorder compared to healthy controls using (-)-[18F]Flusipidine and PET

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Secondary Outcome

- correlation analyses between neuro-psychometric scales, genetic variables and PET-data
- data of safety and tolerability of (-)-[18F]Fluspidine
- development of a kinetic model for analysis of (-)-[18F]Fluspidine PET data

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/07/01
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- age between 18 and 65 years
- caucasian
- without psychotropic medication for at least 2 weeks before PET
- patients with depressive disorder and healthy controls

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Exclusion Criteria

- significant cerebral lesions
- stroke, cocussion, severe subcortical arteriosclerotic encephalitis, multiple sclerosis, brain tumor, dementia, Parkinsons disease
- pregnancy, breast-feeding
- legally incopetent persons
- impaired medical conditions (instable angina pect
oris, recent mycardial infarct, malignant disease)
- severely impaired sight or hearing abilitiy
- contraindications for MRT (metal implants e.g.)

for healty controls: participation in a study for diagnostic or therapeutic purpose by means of ionising radiation within the last 10 years,. if an effective radiation dose of more than 10 mSv can be expected

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Addresses

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    • Universität Leipzig
    • Ritterstraße 26
    • 04109  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Nuklearmedizin
    • Mr.  Prof. Dr. med.  Swen  Hesse 
    • Liebigstraße 18
    • 04103  Leipzig
    • Germany
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    • Univesitätsklinikum Leipzig Klinik und Poliklinik für Nuklearmedizin
    • Ms.  Dipl. Biol.  Franziska  Zientek 
    • Liebigstraße 18
    • 04103  Leipzig
    • 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 complete, follow-up complete
  •   2018/11/30
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* This entry means the parameter is not applicable or has not been set.