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NCT00463580 · ClinicalTrials.gov registry record · Phase 4
A Study of Infliximab for Treatment Resistant Major Depression
A Phase 4 study of Depression, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00463580 is a Phase 4 study of Depression that has completed, run by Emory University. The registered enrollment target is 60 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00463580, a Phase 4 study of Depression, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Major depression is increasingly recognized to be a chronic and highly recurrent condition, which results in significantly increased health problems. One possible mechanism that may contribute to treatment resistance is increased production and release of chemicals called proinflammatory cytokines in patients with major depression. These chemicals mediate the body's response to infectious agents like bacteria and have been shown to be increased by psychological stress. They produce the symptoms that we associate with being sick, including fever, malaise and changes in sleep and appetite. Several lines of evidence indicate that proinflammatory cytokines may contribute to the development of major depression and may thus represent a novel target for the pharmacological treatment of the disorder. The TNF-alpha antagonist, Infliximab (Remicade®), is an infusion style drug approved by the FDA for the treatment of inflammatory conditions like Crohns disease and rheumatoid arthritis. The researchers are conducting a study to see if the infliximab (Remicade®) is more effective than placebo in acutely reducing symptoms of depression in patients who have elevated proinflammatory markers and have not responded to, or been unable to tolerate, at least two previous treatments in the current depressive episode. Proinflammatory markers are measured by a simple blood test for C-Reactive Protein (CRP) levels in the body.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Infliximab
Study Locations (1)
Georgia
- Emory Clinic, Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00463580
The ClinicalTrials.gov registry entry for NCT00463580 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00463580 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT00463580 about?
NCT00463580 is a clinical study titled "A Study of Infliximab for Treatment Resistant Major Depression". Major depression is increasingly recognized to be a chronic and highly recurrent condition, which results in significantly increased health problems. One possible mechanism that may contribute to treatment resistance is increased production and release of chemicals called proinflammatory cytokines i...
What is the current status of trial NCT00463580?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2008-12. Estimated completion is 2011-06.
What conditions does trial NCT00463580 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT00463580?
The interventions under investigation include: Placebo (DRUG), Infliximab (DRUG).
Who is sponsoring clinical trial NCT00463580?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00463580 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.