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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT03983018
Eligibility Criteria:
Inclusion Criteria (Swedish citizens):
1. patient ages 18 to 40 years
2. a duration of illness exceeding 2 years
3. correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S)
4. Global Assessment of Functioning below 50
5. Schizophrenia spectrum disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
6. treatment resistance, i.e. failing to remit despite adequate treatments
7. if female and with any risk for pregnancy, willing to use contraceptives
8. if antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within therapeutic interval.
9. subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
10. immunoglobulin levels within the normal range
Exclusion Criteria:
1. on-going immunomodulatory treatment
2. pregnancy or breast-feeding
3. weight below 40 kg
4. clinically relevant on-going infection
5. chronic infections
6. positive screening test for hepatitis B, C, HIV or tuberculosis
7. any change of psychotropic medication within the previous 4 weeks
8. "much" or "very much improved" already at baseline according to CGI-I i.e. scores of 1 or 2 by the clinician
9. severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
10. unable to make an informed decision to consent to the trial
11. in compulsory treatment
12. treatment with clozapine within the last 2 months
13. previous treatments with immunosuppressive agents
14. malignancy currently or within 2 years prior to inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03983018
Study Brief:
Protocol Section:
NCT03983018