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NCT03006393 · ClinicalTrials.gov registry record · Phase 4
Dynamics of Inflammation and Its Blockade on Motivational Circuitry in Depression
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT03006393: Completed Phase 4 study, sponsored by Emory University.
NCT03006393 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 42 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03006393, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
Reward motivation was assessed by a laboratory effort-based decision-making (EBDM) task. On each trial, participants make a choice about expending more or less physical effort (rapid button pressing) in exchange for varying amounts of monetary rewards. Models of subjective value were fit to each participants' data using maximum likelihood estimation and were compared using Bayesian Information Criterion to identify the model that provides the best fit for participants' responses. Discounting fun
Interventions
- OTHER Placebo
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-08 |
| Est. Completion | 2020-09-26 |
| Phase | Phase 4 |
What the finished NCT03006393 record still lists
NCT03006393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03006393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03006393 about?
NCT03006393 is a clinical study titled "Dynamics of Inflammation and Its Blockade on Motivational Circuitry in Depression". 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 d...
What is the current status of trial NCT03006393?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2016-08. Estimated completion is 2020-09-26.
What interventions are being tested in trial NCT03006393?
The interventions under investigation include: Placebo (OTHER), Infliximab (DRUG).
Who is sponsoring clinical trial NCT03006393?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03006393's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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