Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Depression, sponsored by Emory University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.
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 |
What the finished NCT00463580 record still lists
NCT00463580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00463580's enrollment target sits among peer trials
60 428th of 679 higher than 234 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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
-
Identifying and Treating Depression in the Orthopaedic Trauma Population
RECRUITING · Phase 4
-
Dopaminergic Therapy for Anhedonia - 2
RECRUITING · Phase 4
-
Examining the Effects of Estradiol on Neural and Molecular Response to Reward
RECRUITING · Phase 4
-
Buspirone and Melatonin for Depression Following Traumatic Brain Injury
RECRUITING · Phase 4
-
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
RECRUITING · Phase 4
-
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia