Evaluation of p-glycoprotein alterations in treatment-resistant depression: a [18F]MC225 PET study
Key facts
- Where
- Rome, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- EU 2023-508303-20-01
- Record updated
- 2025. április 16.
- Original description
The primary aim of the study is to assess the involvement of P-gp in TRD by PET/CT, using [18F]MC225 as a radiotracer, by comparing P-gp activity in subjects with TRD and in subjects with treatment respondent depression (DRESP). P-gp activity will be assessed by measuring [18F]MC225 standardized uptake value (SUV) volume distribution (VD) in the whole brain.Read full original descriptionShow less
The primary aim of the study is to assess the involvement of P-gp in TRD by PET/CT, using [18F]MC225 as a radiotracer, by comparing P-gp activity in subjects with TRD and in subjects with treatment respondent depression (DRESP). P-gp activity will be assessed by measuring [18F]MC225 standardized uptake value (SUV) volume distribution (VD) in the whole brain.
Inclusion: Age between 18 and 65 years old; MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5); At least 5 years of education; Capability of completing imaging procedures; 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; Capability of providing written informed consent.
Exclusion: Use of medications with a known effect to P-gp activity; Presence of drug and alcohol abuse/dependence during the last 6 years; Additional psychiatric disorders; Neurological or major medical illnesses; Dementia or mild cognitive impairment; Age <18 years and > 65 years old; Absence of adequate visual and auditory acquity to perform imaging procedures; Claustrophobia and/or inability to tolerate brain PET acquisition that would have an impact on the collection of a good quality scan; Poor peripheral arterial and/or venus access that would interfere with radiopharmaceutical administration and/or blood sampling; Traumatic brain injury with loss of consciousness; Any brain abnormality or microvascular lesions; Pregnancy, breastfeeding, or intention to undergo pregnancy within 6 months from the PET/CT scan; Inability to provide written informed consent.