Infliximab for Depression

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Emory University, Atlanta, GA
Depression+2 More
Infliximab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Inflammation-Induced CNS Glutamate Changes in Depression

See full description

Eligible Conditions

  • Depression

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Depression

Study Objectives

This trial is evaluating whether Infliximab will improve 1 primary outcome and 27 secondary outcomes in patients with Depression. Measurement will happen over the course of Baseline, Week 2.

Week 2
Change in Beck Anxiety Inventory (BAI) Score
Change in CNS glutamate
Change in Columbia Suicide Severity Rating Scale (CSSRS)
Change in Digit Symbol Substitution Task (DSST) Score
Change in Finger Tapping Task (FTT) Score
Change in Hamilton Anxiety Rating Scale (HAM-A) Score
Change in Inventory of Depressive Symptoms-Clinician Rating (IDS-SR) Item 20 Score
Change in Mood and Pleasure Scale (MAP) Score
Change in Multidimensional Fatigue Inventory (MFI) Score
Change in PTSD Checklist for DSM-5 (PCL-5) Score
Change in Reaction Time Task (RTT) Score
Change in Salpetriere Retardation Rating Scale (SRRS) Score
Change in Snaith-Hamilton Pleasure Scale (SHAPS-C) Score
Change in State-Trait Anxiety Inventory (STAI) State Scale Score
Change in Trails Making Test A (TMT-A) Score
Change in plasma C reactive protein (CRP)
Change in plasma IL-10
Change in plasma IL-6
Change in plasma TNF receptor 2 (TNFR2)
Change in plasma interleukin (IL)-1ra
Change in plasma messenger ribonucleic acid (mRNA)
Change in plasma monocyte chemoattractant protein (MCP)-1
Change in plasma soluble IL-6 receptor (sIL-6R)
Change in plasma tumor necrosis factor (TNF)-α
Baseline, Week 2
Change in Gamble Task
Change in Go No-Go Variant Task
Reinforcement Learning Task (RLT)
Subjective Value Task (SLT)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Depression

Side Effects for

Infliximab
Laceration
52%
Headache
38%
Bruises
24%
Sore throat
19%
Muscle tension
14%
Change in urination
10%
Dizziness
10%
Nausea
10%
Itchiness
10%
Fatigue
10%
Heartburn
10%
Pain in joints
5%
Bloody stool
5%
Allergies
5%
Pain in leg
5%
Stomach ache
5%
Vertigo
5%
Change in appetite
5%
Syncope
5%
Change in blood pressure
5%
Motor vehicle accident
5%
Chest pain
5%
Numbness
5%
Migraine
5%
Swelling
5%
Menstruation
5%
Pain in neck
0%
Chills
0%
Pregnancy
0%
Back pain
0%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03006393) in the Infliximab ARM group. Side effects include: Laceration with 52%, Headache with 38%, Bruises with 24%, Sore throat with 19%, Muscle tension with 14%.

Trial Design

2 Treatment Groups

Infliximab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Infliximab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Infliximab
Drug
Participants will be randomized to receive one intravenous (IV) infusion of infliximab.
Placebo
Drug
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 3, week 2
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, day 3, week 2 for reporting.

Who is running the study

Principal Investigator
A. H. M.
Prof. Andrew H Miller, Professor
Emory University

Closest Location

Emory University - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, anxiolytics, and sedative hypnotics) for at least 4 weeks prior to the baseline visit (8 weeks for fluoxetine). No patients will be removed from their psychotropic medications for the sole purpose of participating in the study.
Willing and able to give written informed consent
Primary diagnosis of DSM-V MDD, current, or Bipolar, depressed type as diagnosed by the SCID-V
Score of ≥14 on the Quick Inventory of Depressive Symptomatology (QIDS)-SR-16 or score ≥ 15 on the Patient Health Questionnaire 9 item (PHQ-9)
Absence of significant suicidal ideation defined using the Columbia Suicide Severity Rating Scale - Screen Version (CSSRS)

Patient Q&A Section

What are the signs of inflammation?

"Inflammation is not the only mechanism through which the immune response becomes hypersensitive to inflammatory signals. Tumor necrosis factor-alpha (TNF-α) produced by mast cells, macrophages, and dendritic cells also can contribute to this phenomenon by enhancing the activity of histamine. The increase in histamine activity causes the hypersensitivity to the inflammatory responses in both the intestinal tissue and the extracellular environment." - Anonymous Online Contributor

Unverified Answer

What is inflammation?

"When a patient is treated with a medication that affects the immune system, the immune system can also be affected. The human immune system is part of the body's defense against invading microbes or foreign antigens. When inflammation comes from other causes or when it is stimulated by immune system dysfunctions, the inflammation can cause many symptoms, such as physical or emotional discomfort. Inflammation also causes some disease conditions to occur. Thus, an understanding of the function of the human immune system is one of the key aspects for successful and safe medical treatment." - Anonymous Online Contributor

Unverified Answer

How many people get inflammation a year in the United States?

"Around 8 million people in the United States get inflammation a year. However this represents a large number of patients in a narrow age group because only 6.8% of them were between 50 and 69 years of age." - Anonymous Online Contributor

Unverified Answer

What causes inflammation?

"For the majority of cases, inflammation is the result of a problem with the immune system and can be of many types. There are some cases that are not inflammatory or are caused by infections, where other risk factors such as smoking and exposure to infection are important. Some cases are the result of a number of different kinds of factors, or are unknown. In the majority of cases, however, they are likely to be the result of an infection, and that would certainly lead to inflammation. Those with infectious disease should be treated if they develop symptoms. Those who develop an infection should receive appropriate antibiotics. Those who don't may be treated with steroids. Those who have a specific infection should be treated accordingly." - Anonymous Online Contributor

Unverified Answer

Can inflammation be cured?

"Inflammation has many causes. But in any case, an inflammatory response in the lung or intestine will eventually return to the usual homeostatic condition. It is a relatively simple process. Chronic or persistent inflammation cannot be cured." - Anonymous Online Contributor

Unverified Answer

What are common treatments for inflammation?

"The treatments for inflammatory and autoimmune disorders differ. In general, medication can be used to suppress inflammation [4 to 8 weeks/day], but will most likely weaken the immune system and the body may no longer be able to heal itself if other treatments are necessary. If medication has not helped, then surgery may be required. For any surgical procedure, if the person has a health condition that can be improved with the new procedure, then surgery is preferable. [Power](http://wwwnbsb.nbsbox." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of infliximab?

"Most common side effects of cetuximab and infliximab in a study population of patients with Crohn's disease included: skin hypersensitivity, headache, diarrhea, itchiness, fatigue, fever, and constipation." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating inflammation?

"There is no newly discovered class of medications that target inflammation. Most drug manufacturers do not focus on treating inflammation. Drugs exist that effectively treat arthritis, but do not target inflammation. There are numerous drugs that are effective in treating chronic inflammatory diseases. However, there are not many medications that have been discovered for patients with inflammatory diseases." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for inflammation?

"The data suggest that only a carefully-selected subpopulation of inflammatory disease patients would benefit from clinical trial treatment. Clinicians should be cautious about prescribing trials for inflammatory conditions to non-selective patients, regardless of their disease severity." - Anonymous Online Contributor

Unverified Answer

What is infliximab?

"Even if the level of interleukin-1β is elevated in inflammatory arthritis, it does not seem to be the only determinant of disease activity. Inflammatory arthritis may also be determined by different mechanisms and it must be taken into account when evaluating patients with rheumatoid arthritis on infliximab." - Anonymous Online Contributor

Unverified Answer

Is infliximab typically used in combination with any other treatments?

"The authors found no evidence that treatment with infliximab alone resulted in better clinical improvement than the combination with azathioprine, or that infliximab in combination with adalimumab resulted in greater clinical benefits than the combination with azathioprine." - Anonymous Online Contributor

Unverified Answer

Is infliximab safe for people?

"Infliximab is safe and well-tolerated in the real-world setting, and may reduce complications compared with other TNF antagonists because of its relative simplicity, once-weekly dosing, dose adjustment based on clinical need, and longer duration of action." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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