Actively Recruiting
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Led by Massachusetts General Hospital · Updated on 2025-05-07
100
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 25-50 years
- Able to read and understand English and willing to provide informed consent and comply with the study protocol
- Willing to receive intravenous infusion and have blood drawn
- Circulating blood level of C reactive protein equal or greater than 3 mg/L
- Diagnosed with Major Depressive Disorder
- Moderate depressive symptom severity with a Hamilton Depression Rating Scale score of 15 or higher
- Antidepressant treatment free for at least 4 weeks prior to study entry or on a stable treatment regimen for at least 4 weeks
- Willing to continue current treatment status without changes until study completion (up to three weeks post screening)
- Non-childbearing potential or meeting specific birth control and pregnancy test criteria
You will not qualify if you...
- Medical conditions that could affect study results or participant safety, including recent acute infection or injury, chronic or latent infections, uncontrolled diseases, cancer history, autoimmune or certain neurologic conditions
- Use of active antipsychotic or anticonvulsant medications that interact with infliximab
- Prior use of TNF antagonists or systemic corticosteroids/anti-proliferative agents within one year
- History of liver abnormalities
- Major cognitive impairment
- Active restrictive eating disorder or obsessive compulsive disorder as primary cause of depression
- History of psychotic disorder or bipolar disorder type I/II
- Current substance use disorder of greater than mild severity within last six months
- Suicidal ideation with a score of 3 or more on the Columbia-Suicide Severity Rating Scale
- Electroconvulsive therapy or deep brain stimulation within last year or persistent negative cognitive effects from these treatments
- Presence of a transplanted solid organ
- Use of medications affecting immune or cognitive function such as higher dose benzodiazepines, anti-inflammatory agents, glucocorticoids, statins, or COX-2 inhibitors
- Considered inappropriate for the study due to safety or compliance concerns
- History of allergic reaction to murine products
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
N
Naoise Mac Giollabhui, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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