NCT06136546 Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
| NCT ID | NCT06136546 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2028-08-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.
Eligibility Criteria
Inclusion Criteria: 1. Aged 25-50 years 2. Able to read and understand English and willing to provide informed consent/comply with the study protocol 3. Willingness to complete intravenous infusion and have blood drawn 4. Exhibit circulating blood level of C reactive protein ≥ 3mg/L 5. Diagnosed with Major Depressive Disorder 6. Moderate depressive symptom severity, as indicated by score ≥15 on the Hamilton Depression Rating Scale 7. Antidepressant treatment free for at least 4 weeks prior to study entry or be on a fixed treatment regimen for at least 4 weeks; willingness to continue treatment status (i.e., change/begin new treatment) until study termination 8. Willingness not to begin/change therapies until study termination (maximum of three weeks following screening) 9. Be of non-childbearing potential per the following specific criteria: a. Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilat