[18F]MC225 for Treatment-resistant depression | Major depressive disorder

Inclusion criteria

• {"criterion_text":"- Age between 18 and 65 years old\n- MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5)\n- At least 5 years of education\n- Capability of completing imaging procedures\n- Presence of a current TRD will be additionally required for TRD subjects, according to the most-commonly described criteria used by studies/guidelines for TRD, namely: nonresponse to a minimum of two prior antidepressant treatment attempts of an adequate dose and duration. Non-response will be defined as failure of an antidepressant treatment to induce symptoms remission, according to the NH-mental health study STAR D and experts definition. Treatment resistance/response in the last/current episode should not involve antidepressant which have been proven not to be substrates of P-gp\n- Capability of providing written informed consent"}

Exclusion criteria

• {"criterion_text":"- Age <18 years and > 65 years old\n- Absence of adequate visual and auditory acquity to perform imaging procedures\n- Claustrophobia and/or inability to tolerate brain PET acquisition that would have an impact on the collection of a good quality scan\n- Poor peripheral arterial and/or venus access that would interfere with radiopharmaceutical administration and/or blood sampling\n- Use of medications with a known effect to P-gp activity\n- Presence of drug and alcohol abuse/dependence during the last 6 years\n- Additional psychiatric disorders\n- Neurological or major medical illnesses\n- Dementia or mild cognitive impairment\n- Traumatic brain injury with loss of consciousness\n- Any brain abnormality or microvascular lesions\n- Pregnancy, breastfeeding, or intention to undergo pregnancy within 6 months from the PET/CT scan\n- Inability to provide written informed consent"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"P-gp activity assessed by measuring [18F]MC225 standardized uptake value (SUV) and volume distribution (VD) in the whole brain; overall SUV and DV computed as the sum of the 18 VOIs."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"DV and SUV of [18F]MC225 measured in each of the 9 VOIs per latus (left and right) and compared between TRD and DRESP groups."}
• {"endpoint_text":"- (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)","definition_or_measurement_approach":"Correlation/association analyses between whole-brain [18F]MC225 DV and SUV values and specified clinical severity parameters in TRD subjects."}
• {"endpoint_text":"- (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","definition_or_measurement_approach":"Correlation/association analyses between VOI-specific [18F]MC225 DV and SUV (left and right) and specified clinical severity parameters in TRD subjects."}

Italy

Earliest CTIS Part Ii Submission Date

24-03-2025

Latest Decision Or Authorization Date

16-04-2025

Processing Time Days

23

Number Of Sites

1

Number Of Participants

44

Primary sponsor

Full Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy