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New treatment option for Depressive Disorder, Major
Official title Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
ClinicalTrials.gov ID: NCT06136546
What this study is testing
What is Infliximab?
Infliximab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for depressive disorder, major.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 50
You may be able to join if
- Aged 25-50 years
- Able to read and understand English and willing to provide informed consent/comply with the study protocol
- Willingness to complete intravenous infusion and have blood drawn
- Exhibit circulating blood level of C reactive protein ≥ 3mg/L
- Diagnosed with Major Depressive Disorder
You likely can't join if
- Medical conditions that could confound interpretation or increase participant risk, as indicated via medical history or laboratory testing...
- Active antipsychotic and anticonvulsant medication use (that interact with infliximab)
- Prior use of a TNF antagonist or use of systemic corticosteroids or anti-proliferative agents within one year of study entry
- History of liver abnormalities
- Major cognitive impairment as determined by study investigators
- Active restrictive eating disorder or obsessive compulsive disorder deemed by study investigators to be primary cause of depressive disorder
See the full eligibility criteria
- Aged 25-50 years
- Able to read and understand English and willing to provide informed consent/comply with the study protocol
- Willingness to complete intravenous infusion and have blood drawn
- Exhibit circulating blood level of C reactive protein ≥ 3mg/L
- Diagnosed with Major Depressive Disorder
- Moderate depressive symptom severity, as indicated by score ≥15 on the Hamilton Depression Rating Scale
- 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...
- Willingness not to begin/change therapies until study termination (maximum of three weeks following screening)
- 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...
- 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...
- Active antipsychotic and anticonvulsant medication use (that interact with infliximab)
- Prior use of a TNF antagonist or use of systemic corticosteroids or anti-proliferative agents within one year of study entry
- History of liver abnormalities
- Major cognitive impairment as determined by study investigators
- Active restrictive eating disorder or obsessive compulsive disorder deemed by study investigators to be primary cause of depressive disorder
- History of a psychotic disorder or Bipolar disorder type I/II
- Current substance use disorder (i.e., present in last six months), of greater than mild severity
- Suicidal ideation based on a score ≥3 on the Columbia-Suicide Severity Rating Scale
- Electroconvulsive therapy (ECT)/deep brain stimulation (DBS) within the last year, or report of persistent negative cognitive effects of ECT/DBS
- Presence of a transplanted solid organ
- 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...
- Considered by the study investigators to be inappropriate for the study due to safety concerns or to be unlikely to complete the protocol
- History of allergic response to murine products
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.