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NCT05823532 · ClinicalTrials.gov registry record · Phase 4

Anti-Inflammatory Challenge in Schizophrenia

A Phase 4 study of Schizophrenia, sponsored by Emory University.

Recruiting
Registry status
Phase 4
Development phase
20
Enrollment target
2
Study locations

NCT05823532: Recruiting Phase 4 study of Schizophrenia, sponsored by Emory University.

NCT05823532 is a Phase 4 study of Schizophrenia that is actively recruiting participants, run by Emory University. The registered enrollment target is 20 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05823532, a Phase 4 study of Schizophrenia, is actively recruiting participants, sponsored by Emory University.

RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

This research project will explore negative symptoms of schizophrenia, such as motivational deficits, by examining the relationship between inflammation and reward-related brain regions. To accomplish this, we will administer a single infusion of either the anti-inflammatory medication infliximab or placebo (n=10 per group) to patients with high inflammation. This study is important because schizophrenia can be a chronic and debilitating neuropsychiatric disorder and negative symptoms are some of the most difficult aspects of schizophrenia associated with worst functional outcomes. These symptoms do not typically respond to antipsychotic therapies, and as such, there are no current medications to treat negative symptoms.

Primary Outcome

Change in Bold Oxygen Level Dependent (BOLD) Activation in the Ventral Striatum during "Win" Monetary Incentive Delay (MID) Task between Infliximab and Placebo (time frame:1-3 days before intervention and 2 weeks post intervention (MID occurs during scans). Activation response in ventral striatum in response to reward anticipation: Infliximab (vs placebo)-treated patients will exhibit a) increased activation in ventral striatum in response to reward. Mixed-effects models for repeated measures (M

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Infliximab

Study Locations (2)

Georgia

  • Grady Memorial Hospital - Atlanta
  • Emory University Hospital - Atlanta

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-04-18
Est. Completion 2028-03
Phase Phase 4
Emory University

1,208 total trials

What NCT05823532 shows while recruiting

NCT05823532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05823532 reports a single indexed study location in Georgia.

Frequently Asked Questions

What is clinical trial NCT05823532 about?

NCT05823532 is a clinical study titled "Anti-Inflammatory Challenge in Schizophrenia". This research project will explore negative symptoms of schizophrenia, such as motivational deficits, by examining the relationship between inflammation and reward-related brain regions. To accomplish this, we will administer a single infusion of either the anti-inflammatory medication infliximab or...

What is the current status of trial NCT05823532?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-04-18. Estimated completion is 2028-03.

What conditions does trial NCT05823532 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT05823532?

The interventions under investigation include: Placebo (DRUG), Infliximab (DRUG).

Who is sponsoring clinical trial NCT05823532?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05823532 being conducted?

This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Schizophrenia

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 NCT05823532's enrollment target sits among peer trials

20 286th of 315 higher than 24 of 315 other Schizophrenia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Schizophrenia 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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Source: ClinicalTrials.gov NCT05823532, the US trial registry maintained by the National Library of Medicine. NCT05823532 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.