Skip to content

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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008321
Enrollment
45
Registered
2015-05-06
Start date
2015-07-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F34.1 F31.3 F31.4 F31.5 F32 F33

Interventions

Group 1: 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

Sponsors

Universität Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
- 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

Countries

Germany

Contacts

Public ContactFranziska Zientek

Univesitätsklinikum Leipzig Klinik und Poliklinik für Nuklearmedizin

franziska.zientek@medizin.uni-leipzig.de+49 341/ 97 18048

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026