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TNF Antagonist

Infliximab for Depression

Phase 4
Waitlist Available
Led By Ebrahim Haroon, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 3, week 2
Awards & highlights

Study Summary

This trial is designed to study the effects of inflammation on the brain's levels of glutamate, a neurotransmitter, in order to understand how inflammation may be linked to neuropsychiatric illnesses.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 3, week 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 3, week 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Central Nervous System (CNS) Glutamate
Secondary outcome measures
Digit Symbol Substitution Task (DSST) Score
Finger Tapping Task (FTT) Score
Inventory of Depressive Symptoms-Clinician Rating (IDS-SR) Score
+10 more

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393
52%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Change in urination
10%
Heartburn
10%
Fatigue
10%
Nausea
10%
Dizziness
10%
Itchiness
5%
Menstruation
5%
Pain in joints
5%
Migraine
5%
Stomach ache
5%
Syncope
5%
Chest pain
5%
Swelling
5%
Bloody stool
5%
Pain in leg
5%
Allergies
5%
Change in blood pressure
5%
Vertigo
5%
Change in appetite
5%
Numbness
5%
Motor vehicle accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InfliximabExperimental Treatment1 Intervention
Participants will be randomized to receive one intravenous (IV) infusion of infliximab.
Group II: PlaceboPlacebo Group1 Intervention
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
2017
Completed Phase 4
~3280

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,253 Total Patients Enrolled
666 Trials studying Depression
251,562 Patients Enrolled for Depression
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,510 Total Patients Enrolled
59 Trials studying Depression
8,994 Patients Enrolled for Depression
Ebrahim Haroon, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
169 Total Patients Enrolled
1 Trials studying Depression
169 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Washington
Georgia
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
Therapeutic Advances in PsychopharmacologyJournal
Anti-cytokine Agents for Anhedonia: Targeting Inflammation and the Immune System to Treat Dimensional Disturbances in Depression
Lee, Yena, Mehala Subramaniapillai, Elisa Brietzke, Rodrigo B. Mansur, Roger C. Ho, Samantha J. Yim, and Roger S. McIntyre. 2018. “Anti-cytokine Agents for Anhedonia: Targeting Inflammation and the Immune System to Treat Dimensional Disturbances in Depression”. Therapeutic Advances in Psychopharmacology. SAGE Publications. doi:10.1177/2045125318791944.
clinicaltrials.govStudy
Inflammation-Induced CNS Glutamate Changes in Depression
Andrew H Miller 2017. "Inflammation-Induced CNS Glutamate Changes in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03004443.
~3 spots leftby Apr 2025
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