2023-504181-38-00RecruitingPhase 2/3
Assessment of microglial activation in patients with schizophrenia stratified for C4 complement by PET using [18F]DPA-714
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 3 Mar 2023
- Start date
- 17 Nov 2025
- Lead sponsor
- Institut National De La Sante Et De La Recherche Medicale
- Diseases
- Schizophrenia
- EU CT number
- 2023-504181-38-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 75
- 2 sites 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
- 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
Other illness
- Progressive chronic inflammatory disease (rheumatic, digestive, autoimmune)
- 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
Lab values
- 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
Other
- Adult subject to legal protection (guardianship of a tutor, or safeguard of justice)
- Claustrophobia
- Current pregnancy, breastfeeding
- Person refusing to be informed of a significant health finding discovered in the research
- Person deprived of liberty by administrative or judicial decision
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux De Paris | Creteil | France | Recruiting |
| French Alternative Energies And Atomic Energy Commision | ORSAY | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.