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NCT06136546
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Phase 2 trial testing Infliximab in Depressive Disorder, Major in 100 participants. Currently enrolling.
31 August 2028
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 23 January 2025 |
| Primary completion | 31 August 2028 |
| Estimated completion | 31 January 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Infliximab (infliximab) — full drug profile →
- Placebo
Conditions studied
- Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
- Inflammation — all drugs for Inflammation →
Sponsor
Massachusetts General Hospital
Who can join
Adults 25 to 50, any sex, with Depressive Disorder, Major or Inflammation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Systemic Inflammation at the Crossroad of Major Depressive Disorder and Comorbidities: A Narrative Review.
Vitali E, Cattane N, D'Aprile I, Petrillo G, et al · · 2025 · cited 2× · PMID 41096651 · DOI 10.3390/ijms26199382 -
Unraveling the meta-hallmarks between senescent and tumor cells: A new perspective for senolytic drug discovery.
Liu W, Fan B, Fang T, Li H, et al · · 2025 · cited 1× · PMID 41132829 · DOI 10.1016/j.apsb.2025.08.010 -
Botulinum Toxin: An Unconventional Tool for the Treatment of Depression?
Gambini M, Gurrieri R, Russomanno G, Cecchini G, et al · · 2025 · PMID 41008331 · DOI 10.3390/brainsci15090971
Verify or expand the search:
- PubMed search for NCT06136546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Infliximab
Trials testing the same drug.
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- NCT07415473 — Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease · Phase 4 · not yet recruiting
- NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
- NCT07297069 — Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial · Phase 2 · not yet recruiting
Other recruiting trials for Depressive Disorder, Major
Currently open trials in the same condition.
- NCT07227454 — A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder · Phase 3 · recruiting
- NCT07258485 — A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major · recruiting
- NCT07059234 — The Motor Activity - Subjective Energy (MASE) Project · NA · recruiting
- NCT06982820 — Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia · NA · recruiting
- NCT05553353 — Dosing rTMS for Depression Post-SCI · NA · recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
- NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06136546 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06136546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing