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Tiny study probes why clozapine beats other schizophrenia drugs

NCT ID NCT05741502

Knowledge-focused Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to compare the effects of clozapine versus other antipsychotic medications on inflammation in people with treatment-resistant schizophrenia. Researchers measured inflammatory markers like interleukin-6 in a small group of participants. The study was terminated early with only 5 people enrolled, so no firm conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clozapine
What this could lead to
If successful, this could help explain why clozapine works better for some people with treatment-resistant schizophrenia, potentially guiding future treatments.
What could go wrong
This was a very small, terminated study with only 5 participants, so results are not reliable. It was exploratory, meaning it was designed to generate ideas, not prove anything.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

5 people

The number who actually took part.

Started

Aug 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All participants: * Between 18 and 65 years of age * Physically healthy (no clinically significant unstable medical condition as confirmed by medical history and physical examination) * Able to give informed consent * Treatment-Refractory Schizophrenia Clozapine treatment group (n = 30) Individuals treated with Clozapine consistently for a minimum of 6 months Non-Clozapine treatment group Continued treatment with non-Clozapine antipsychotic but would be eligible for Clozapine with the provider/patient electing to not pursue such for clinical reasons, consistently treated for at least 6 months Exclusion Criteria: * Clinically significant medical condition; cardiovascular, pulmonary, endocrine, or renal condition requiring in depth medical treatment * Active or recent (within 4 weeks) bacterial or viral infection * Chronic viral infection (hepatitis, HIV) * History of autoimmune, or chronic inflammatory condition * Current treatment with lithium * Treatment with Clozapine in the past 6 months * Current treatment with immunomodulatory or anti-inflammatory therapy * Vaccination within the past 3 months * Current alcohol or substance use disorder of moderate or severe severity * Intellectual disability (i.e. intelligence quotient \<70) * Unwilling or unable to sign informed consent document * Pregnancy * Any patient deemed ineligible by PI discretion

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Conditions

The condition(s) this trial relates to.

Schizophrenia, Treatment-Resistant treatment-refractory schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment resistant schizophrenia

Contacts and locations

Locations

  • Ohio State University Harding Hospital

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.