Active, not recruitingPhase 2
Brain scan study of a transport protein in treatment-resistant depression
Uses a brain PET scan to compare a protein in adults with treatment-resistant depression.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Rome, ItalySee the site
- Trial code
- Registry title
- Evaluation of p-glycoprotein alterations in treatment-resistant depression: a [18F]MC225 PET study
- Status
- Active, not recruiting
- Phase
- Phase 2
- People taking part
- 44 people, planned
- Started
- 14 Jul 2025
- Expected to end
- 15 Apr 2027
- Type of study
- Interventional
- Record updated
- 16 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with major depression. Some have depression that did not respond to treatment, and some have depression that responded.
- Age
- 18 to 65 years
- Sex
- All sexes
- Disease stage
- Major depressive disorder (MDD) diagnosed by DSM-5. One group has treatment-resistant depression: no response to at least two earlier antidepressant treatments of adequate dose and length. The other group has depression that responds to treatment.
- Earlier treatment
- People with treatment-resistant depression must not have responded to at least two earlier antidepressants. Medicines known to affect P-gp activity cannot be used.
Main reasons for not taking part
- Another psychiatric disorder
- Drug or alcohol abuse or dependence in the last 6 years
- Neurological or major medical illness, dementia or mild cognitive impairment
- Claustrophobia or being unable to tolerate a brain PET scan
- Pregnancy, breastfeeding, or plans to become pregnant within 6 months of the scan
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNo longer taking part
About the trial
What the trial wants to find out
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.
Data and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Evaluation of p-glycoprotein alterations in treatment-resistant depression: a [18F]MC225 PET study
- Plain-language title
- Brain scan study of a transport protein in treatment-resistant depressionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 16 April 2025