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2023-508303-20-01RecruitingPhase 2

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
44 (estimated)
First submitted
18 Dec 2024
Start date
14 Jul 2025
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diseases
Depression
EU CT number
2023-508303-20-01

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 44
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of medications with a known effect to P-gp activity
  • Presence of drug and alcohol abuse/dependence during the last 6 years

Other illness

  • Additional psychiatric disorders
  • Neurological or major medical illnesses
  • Dementia or mild cognitive impairment

Age

  • Age <18 years and > 65 years old

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRomeItalyRecruiting

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