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NCT05741502 · ClinicalTrials.gov registry record · Phase 4

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine

A Phase 4 study, sponsored by Ohio State University.

Terminated
Registry status
Phase 4
Development phase
5
Enrollment target

NCT05741502: Clinical Trial Phase 4 study, sponsored by Ohio State University.

NCT05741502 is a Phase 4 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05741502, a Phase 4 study, was terminated before completion, sponsored by Ohio State University.

TERMINATED
Registry status
Phase 4
Development phase
5 participants
Enrollment target

Study Summary

The specific aim of this protocol is to compare Clozapine treatment vs Non-Clozapine antipsychotic treatment in a population of treatment-refractory individuals with schizophrenia. Specifically, it is to test if Clozapine leads to a decrease in levels of inflammatory markers, namely interleukin-6 but with an exploratory view of other markers. Clozapine has superior efficacy and is the only medication approved for treatment-refractory schizophrenia in addition to decreasing the risk of suicidal behavior as well. It is unclear why Clozapine has increased efficacy from a mechanistic viewpoint. We will look at the role of inflammatory markers and assess them 1x along with rating scales for psychosis and suicidality, the other entities which Clozapine has been shown to improve.

Primary Outcome

Comparison in interleukin-6 between Clozapine and non-Clozapine group

Interventions

  • DRUG Clozapine
  • DRUG Antipsychotics,Other (non-Clozapine)

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2023-08-16
Est. Completion 2026-01-23
Phase Phase 4
Ohio State University

552 total trials

Why NCT05741502 stopped before completion

NCT05741502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Clozapine is the first listed.

NCT05741502 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05741502 about?

NCT05741502 is a clinical study titled "An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine". The specific aim of this protocol is to compare Clozapine treatment vs Non-Clozapine antipsychotic treatment in a population of treatment-refractory individuals with schizophrenia. Specifically, it is to test if Clozapine leads to a decrease in levels of inflammatory markers, namely interleukin-6 bu...

What is the current status of trial NCT05741502?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2023-08-16. Estimated completion is 2026-01-23.

What interventions are being tested in trial NCT05741502?

The interventions under investigation include: Clozapine (DRUG), Antipsychotics,Other (non-Clozapine) (DRUG).

Who is sponsoring clinical trial NCT05741502?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05741502's enrollment target sits among peer trials

5 1989th of 2000 higher than 7 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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Source: ClinicalTrials.gov NCT05741502, the US trial registry maintained by the National Library of Medicine. NCT05741502 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.