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

Early Phase 1
Conditions
Dysthymia
F34.1
F31.3
F31.4
F31.5
F32
F33
Bipolar affective disorder, current episode mild or moderate depression
Bipolar affective disorder, current episode severe depression without psychotic symptoms
Bipolar affective disorder, current episode severe depression with psychotic symptoms
Registration Number
DRKS00008321
Lead Sponsor
niversität Leipzig
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
45
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Examination of the central sigma-1-receptor availibility in patients with major depressive disorder compared to healthy controls using (-)-[18F]Flusipidine and PET
Secondary Outcome Measures
NameTimeMethod
- correlation analyses between neuro-psychometric scales, genetic variables and PET-data<br>- data of safety and tolerability of (-)-[18F]Fluspidine <br>- development of a kinetic model for analysis of (-)-[18F]Fluspidine PET data
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