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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT07281105
Eligibility Criteria:
Key Inclusion Criteria:
1. Physician diagnosis of SLE;
2. Report NPSLE symptoms on the screening survey recommended by EULAR guideline but limited to a subset of the psychiatric manifestations questions and using a cut-off score of at least 5, with a minimum of 2.5 being scored on section 1;
3. Score ≤ 85 on the RBANS total index (≤ 1 SD below the normative mean of 100)
Key Exclusion Criteria:
1. Male and female subjects \<18 or \>69 years;
2. Change in medication that may affect mood or cognition including prednisone, antidepressant medications, analgesics including opioids, or stimulants within the last 4 weeks;
3. Metabolic derangement defined as liver function tests \>3x upper limit of normal, or severe renal disease defined as calculated creatinine clearance\<30 mL;
4. Severe psychiatric disease including schizophrenia, psychosis, suicidal depression, or substance abuse disorder;
5. Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)\* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule);
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT07281105
Study Brief:
Protocol Section:
NCT07281105