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Evaluation of p-glycoprotein alterations in treatment-resistant depression: a [18F]MC225 PET study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508303-20-01
Acronym
P-gp-TRD
Enrollment
44
Registered
2025-04-16
Start date
2025-07-14
Completion date
Unknown
Last updated
2025-04-16

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

Conditions

depression

Brief summary

To assess between groups differences as for whole-brain DV and SUV of [18F]MC225 (outcome variables) in TRD and DRESP. Overall SUV and DV will be computed as the sum of the 18 VOIs.

Detailed description

To assess between groups differences as for DV and SUV of [18F]MC225 in each VOI, both on the right and left latus, in TRD and DRESP, (specifically in TRD subjects) To assess the relationship between [18F]MC225 DV and SUV on the whole brain, and clinical parameters related to the severity of the disease (i.e. duration of disease, number of episodes, number of previous attempted suicides, current episode of attempted suicide, previous psychosis, current psychosis, previous drug abuse, previous pharmacotherapy), (specifically in TRD subjects) To assess the relationship between [18F]MC225 DV and SUV at the level of each VOI, either left or right, and the aforementioned clinical parameters related to the severity of the disease

Interventions

DRUG18FMC225_FPG

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To assess between groups differences as for whole-brain DV and SUV of [18F]MC225 (outcome variables) in TRD and DRESP. Overall SUV and DV will be computed as the sum of the 18 VOIs.

Secondary

MeasureTime frame
To assess between groups differences as for DV and SUV of [18F]MC225 in each VOI, both on the right and left latus, in TRD and DRESP, (specifically in TRD subjects) To assess the relationship between [18F]MC225 DV and SUV on the whole brain, and clinical parameters related to the severity of the disease (i.e. duration of disease, number of episodes, number of previous attempted suicides, current episode of attempted suicide, previous psychosis, current psychosis, previous drug abuse, previous pharmacotherapy), (specifically in TRD subjects) To assess the relationship between [18F]MC225 DV and SUV at the level of each VOI, either left or right, and the aforementioned clinical parameters related to the severity of the disease

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026