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Monoclonal Antibodies
Infliximab for Depression
Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Major Depressive Disorder
Moderate depressive symptom severity, as indicated by score ≥15 on the Hamilton Depression Rating Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2
Summary
This trial aims to see if giving a medication called infliximab through an IV can help improve brain function in depressed individuals who also have signs of inflammation.
Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder and inflammation (CRP ≥ 3mg/L). Participants must have moderate depression, not be on new antidepressants for the last 4 weeks, and either be unable to become pregnant or use reliable contraception. They should agree not to change their treatment during the study.
What is being tested?
The trial tests if infliximab, given through an IV, can improve thinking speed and problem-solving in people with depression linked to inflammation. It's a randomized controlled trial comparing infliximab against a placebo.
What are the potential side effects?
Infliximab may cause side effects like infection risk increase due to immune system suppression, infusion reactions such as fever or chills, headache, digestive issues, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Major Depressive Disorder.
Select...
I have moderate depression based on a specific depression scale score.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ repeated measures over two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~repeated measures over two weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Executive Function (TestMyBrain: Choice Reaction Time)
Psychomotor Speed (TestMyBrain: Simple Reaction Time)
Secondary study objectives
Concentrations of circulating C reactive protein
Dimensional Anhedonia Rating Scale (17-item; range 0-68)
Hamilton Depression Rating Scale (17-item; range 0-54)
Side effects data
From 2020 Phase 4 trial • 42 Patients • NCT0300639352%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Nausea
10%
Change in urination
10%
Heartburn
10%
Fatigue
10%
Dizziness
10%
Itchiness
5%
Pain in joints
5%
Chest pain
5%
Stomach ache
5%
Syncope
5%
Menstruation
5%
Migraine
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 in this arm will receive 5 mg/kg of infliximab via an in-dwelling catheter.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive saline as placebo via an in-dwelling catheter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
2017
Completed Phase 4
~3350
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,720 Total Patients Enrolled
27 Trials studying Inflammation
2,202 Patients Enrolled for Inflammation