CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Infliximab +1 moredrug
Likely dose
Infliximab 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03006393
NCT03006393Phase 4Completed

Dynamics of Inflammation and Its Blockade on Motivational Circuitry in Depression

Emory University·interventional·Posted Dec 30, 2016·Updated Nov 18, 2021

In Brief

A Phase 4 clinical trial evaluating Infliximab and Placebo for Depression. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The main purpose of this study is to examine the effects of infliximab on measures related to depression symptoms. Infliximab is also known by its brand name Remicade. Infliximab, or Remicade, is given to by an intravenous (IV) needle and is currently used to treat rheumatoid arthritis and Crohn's disease. Infliximab is thought to help these conditions because it reduces inflammation in the body. Infliximab (Remicade) reduces inflammation by blocking a chemical in the body called tumor necrosis factor (TNF)-alpha. This chemical produces inflammation. Inflammatory chemicals in the body like TNF-alpha appear to be increased in some people with major depression. Researchers believe that a drug like infliximab, which blocks TNF-alpha, may be helpful in treating depression. This is a double-blind, placebo-controlled study in which participants will be randomized to receive one infusion of infliximab or placebo. The study will assess neuroimaging measures of corticostriatal circuitry before and after a placebo-controlled pharmacologic blockade of inflammation in 80 depressed patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 30, 2016
Enrollment StartAug 1, 2016
Primary CompletionSep 26, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.5 years ago

Interventions

Infliximabdrug

One infusion of Infliximab (Remicade) will be administered intravenously (IV) at 5 mg/kg body weight over a two hour period.

Placeboother

One infusion of placebo treatment will be administered intravenously (IV) over a two hour period.