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Assessment of microglial activation in patients with schizophrenia stratified for C4 complement by PET using [18F]DPA-714

Phase 1
Conditions
pathology studied is schizophrenia
MedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873
Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Registration Number
CTIS2023-504181-38-00
Lead Sponsor
Institut National De La Sante Et De La Recherche Medicale
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
75
Inclusion 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

Exclusion Criteria

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
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