Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT07146802
Eligibility Criteria:
Inclusion Criteria:
* Adults, 18 - 65 years of age.
* Patient affiliated to health insurance
* Inpatients and outpatients with DSM-5 diagnosis of schizophrenia spectrum disorder.
* Presence of positive symptoms at inclusion (PANSS delusions, suspiciousness or grandiosity ≥3).
* Stable condition with no expected changes in medication or symptoms during the last 3 months (information from clinical services, note that stable condition includes lack of suicidality).
* Patient providing informed consent.
Exclusion Criteria:
* Having received MCT in the previous year.
* Neurological disorder, or severe medical condition other than psychosis
* A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).
* Patient considered by his psychiatrist to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors)
* Patient in an exclusion period defined by another research protocol
* Patient involved in another Investigational Medicinal Product trial
* Patient under guardianship (i.e. French "tutelle")
* Patients deprived of freedom because of a judicial measure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07146802
Study Brief:
Protocol Section:
NCT07146802