Actively Recruiting
The Role of Inflammation in Cognitive Dysfunction in Acute Depression as Determined by Experimental Inhibition of Tumor Necrosis Factor-alpha Signaling in a Randomized Controlled Trial
Led by Massachusetts General Hospital · Updated on 2025-05-07
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether blocking tumor necrosis factor signaling with infliximab, given through an intravenous infusion, can improve thinking speed and executive function in adults with major depressive disorder who show signs of inflammation. This randomized controlled trial focuses on adults aged 25 to 50 who have elevated C reactive protein levels and moderate depression. The study aims to better understand the role of inflammation in cognitive difficulties associated with depression. Participants are randomly assigned to receive either infliximab at a dose of 5 mg per kilogram or a saline placebo through an in-dwelling catheter. Over two weeks, participants will complete daily remote assessments of depression symptoms and cognitive function using a mobile platform called TestMyBrain, alongside in-person evaluations by clinicians. Blood samples will be collected at the start and after one week to measure inflammatory markers and tumor necrosis factor levels. Throughout the study, researchers will monitor changes in psychomotor speed and executive function, with primary outcomes measured repeatedly over two weeks. Secondary assessments include depression severity scales and blood levels of C reactive protein. Participants will be closely observed for safety and adherence to the protocol during this period. The trial is led by Massachusetts General Hospital and follows a triple-blinded design to ensure unbiased results.
CONDITIONS
Brief 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 follow the study protocol
- Willing to receive intravenous infusion and have blood drawn
- Circulating blood level of C reactive protein 3 mg/L or higher
- Diagnosed with Major Depressive Disorder
- Moderate depressive symptom severity with a score of 15 or higher on the Hamilton Depression Rating Scale
- Antidepressant treatment free for at least 4 weeks prior or on a stable treatment regimen for at least 4 weeks and willing to maintain this until study end
- Willing not to start or change therapies until study completion (up to three weeks after screening)
- Non-childbearing potential by specific criteria or, if of childbearing potential, meeting strict birth control requirements and having a negative pregnancy test before infusion
You will not qualify if you...
- Medical conditions that increase risk or affect study results, including recent acute injury or infection, chronic or latent infections, uncontrolled diseases, cancer history, autoimmune or neurologic conditions affecting cognition
- Use of active antipsychotic or anticonvulsant medications that interact with infliximab
- Prior use of TNF antagonists or certain immune-affecting medications 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 or Bipolar disorder type I/II
- Current moderate to severe substance use disorder within last six months
- Suicidal ideation with high severity score
- Recent electroconvulsive therapy or deep brain stimulation or persistent negative effects from them
- Presence of transplanted solid organ
- Use of medications affecting immune or cognitive function including certain benzodiazepines and anti-inflammatory agents during the study
- Considered unsafe or unlikely to complete protocol by investigators
- History of allergic reaction to murine products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive an intravenous infusion of infliximab or placebo and complete cognitive and symptom assessments.
1 infusion visit (in-person) and daily remote assessments
Duration - Up to 2 weeks after treatment
Participants complete in-person clinician-rated assessments and blood draws to evaluate depressive symptoms and immune biomarkers.
2 in-person visits (baseline and Week 1) plus assessment at Week 2
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
N
Naoise Mac Giollabhui, PhD
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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