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Evaluation of p-glycoprotein alterations in treatment-resistant depression: a [18F]MC225 PET study
EU CTIS ID: 2023-508303-20-01
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- Use of medications with a known effect to P-gp activity
- Presence of drug and alcohol abuse/dependence during the last 6 years
See the full eligibility criteria
- 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 <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
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.