Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
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.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 25 Years to 50 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening); or b. Childbearing potential and meets the following criteria: i. A negative serum pregnancy test within thirty days of infusion (may be repeated closer to infusion date at the discretion of the PI or study staff) and abstinent after the negative serum pregnancy test and prior to infusion; or ii. Using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent; iii. Continuously use one of the following methods of birth control over the last six months: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. Exclusion Criteria: 1. Medical conditions that could confound interpretation or increase participant risk, as indicated via medical history or laboratory testing; exclusionary medical conditions will include: i. acute injury/infection within one week of study initiation or infection within one month of study initiation that required antibiotic/antiviral treatment ii. chronic infection (e.g., hepatitis B or C or HIV) or history of Covid 19 infection within the past 6 months or with persisting symptoms. iii. latent infection (e.g., tuberculosis, fungal infections), or history of recurrent infections, iv. uncontrolled cardiovascular, endocrine, hematologic, hepatic, renal or neurologic disease (as determined by medical history, physical exam and laboratory testing) v. cancer history vi. autoimmune conditions; neurologic conditions (controlled) that are known to substantially impact cognitive function (e.g., stroke). Of note, stable medical conditions such as diabetes and cardiovascular disease, will be allowed in the study as they can contribute to endogenous inflammation. 2. Active antipsychotic and anticonvulsant medication use (that interact with infliximab) 3. Prior use of a TNF antagonist or use of systemic corticosteroids or anti-proliferative agents within one year of study entry 4. History of liver abnormalities 5. Major cognitive impairment as determined by study investigators 6. Active restrictive eating disorder or obsessive compulsive disorder deemed by study investigators to be primary cause of depressive disorder 7. History of a psychotic disorder or Bipolar disorder type I/II 8. Current substance use disorder (i.e., present in last six months), of greater than mild severity 9. Suicidal ideation based on a score ≥3 on the Columbia-Suicide Severity Rating Scale 10. Electroconvulsive therapy (ECT)/deep brain stimulation (DBS) within the last year, or report of persistent negative cognitive effects of ECT/DBS 11. Presence of a transplanted solid organ 12. Medication use affecting immune or cognitive function: i. Chronic use (\>1 month) of a benzodiazepine more than the equivalent of 2 mg of lorazepam ii. Use of anti-inflammatory agents during the study: non-steroidal anti-inflammatory agents (NSAIDs) (excluding 81mg of aspirin), glucocorticoid containing medicines or statins, or cyclooxygenase-2 (COX-2) inhibitors 13. Considered by the study investigators to be inappropriate for the study due to safety concerns or to be unlikely to complete the protocol 14. History of allergic response to murine products
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Naoise Mac Giollabhui, PhD · Study contact · 6177241000 · nmacgiollabhui@mgh.harvard.eduNaoise Mac Giollabhui, PhD · Principal investigatorMore trials in Boston