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Assessment of microglial activation in patients with schizophrenia stratified for C4 complement by PET using [18F]DPA-714
EU CTIS ID: 2023-504181-38-00
What this study is testing
To assess the correlation between cortical neuro-inflammation quantified by Positrons Emission Tomography (PET) using [18F]DPA-714, and genetic determinants of C4 expression in patients with schizophrenia and healthy volunteers.
- Phase II and Phase III (Integrated)
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
- Male or Female, aged from 18 to 55, patients with schizophrenia diagnostic according to DSM-5 and presenting HLA 8.1 AH haplotype (8.1 AH+) or presenting no HLA 8.1 AH haplotype ( (8.1 AH-)
- Male or Female healthy controls aged from 18 to 55 matched regarding age, sex, HLA/C4 according to patients (8.1 AH+ or 8.1 AH-).
- Having Efficient Contraception for women of reproductive age ( contraception will be considered effective from the moment the patient declares the use of an oral contraceptive, the presence of an IUD other than copper ones, a diaphragm or a contraceptive implant, or the completion of a tubal ligation or sterilization by Essure process)
- Be able to understand research objectives and procedures
- Be affiliated with or be a beneficiary of a social security scheme
- Genetic criterion: TSPO genotype allowing tracer fixation (90% of subjects)
You likely can't join if
- Progressive chronic inflammatory disease (rheumatic, digestive, autoimmune)
- Adult subject to legal protection (guardianship of a tutor, or safeguard of justice)
- For healthy volunteers only : Pathology or history of Axis 1 psychiatric pathology investigated by the validated French version of the MINI (Mini International Neuropsychiatric Interview) questionnaire
- Known hypersensitivity to radiopharmaceutical ([18F]DPA-714 or one of the excipients)
- History of severe renal or liver failure
- Contraindication to MRI : pacemaker or neurosensory pacemaker or implantable defibrillator; clip on an aneurysm or clip on a vascular malformation of the brain; ferromagnetic intraocular or cerebral foreign body; prosthesis or ferro-metallic objects or fragments mobilizable magnetic; cochlear implants; peripheral stimulator; ventriculoperitoneal neurosurgical bypass valves; permanent eye or lip makeup. Automatic injection device type insulin pump, blood glucose sensor
See the full eligibility criteria
- Male or Female, aged from 18 to 55, patients with schizophrenia diagnostic according to DSM-5 and presenting HLA 8.1 AH haplotype (8.1 AH+) or presenting no HLA 8.1 AH haplotype ( (8.1 AH-)
- Male or Female healthy controls aged from 18 to 55 matched regarding age, sex, HLA/C4 according to patients (8.1 AH+ or 8.1 AH-).
- Having Efficient Contraception for women of reproductive age ( contraception will be considered effective from the moment the patient declares the use of an oral contraceptive, the presence of an IUD other than copper ones, a diaphragm or a contraceptive implant, or the completion of a tubal ligation or sterilization by Essure process)
- Be able to understand research objectives and procedures
- Be affiliated with or be a beneficiary of a social security scheme
- Genetic criterion: TSPO genotype allowing tracer fixation (90% of subjects)
- Have signed a free and informed consent
- Progressive chronic inflammatory disease (rheumatic, digestive, autoimmune)
- Adult subject to legal protection (guardianship of a tutor, or safeguard of justice)
- For healthy volunteers only : Pathology or history of Axis 1 psychiatric pathology investigated by the validated French version of the MINI (Mini International Neuropsychiatric Interview) questionnaire
- Known hypersensitivity to radiopharmaceutical ([18F]DPA-714 or one of the excipients)
- History of severe renal or liver failure
- Contraindication to MRI : pacemaker or neurosensory pacemaker or implantable defibrillator; clip on an aneurysm or clip on a vascular malformation of the brain; ferromagnetic intraocular or cerebral foreign body; prosthesis or ferro-metallic objects or fragments mobilizable magnetic; cochlear implants; peripheral stimulator; ventriculoperitoneal neurosurgical bypass valves; permanent eye or lip makeup. Automatic injection device type insulin pump, blood glucose sensor
- Claustrophobia
- Current pregnancy, breastfeeding
- Person refusing to be informed of a significant health finding discovered in the research
- Participation in research or management of a pathology with ionizing radiation exposure as part of a nuclear medicine examination (PET, SPECT, NM) in the year prior to or during the exclusion period of another research
- Person deprived of liberty by administrative or judicial decision
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. 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.