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Could a common food preservative help treat Hard-to-Treat schizophrenia?

NCT ID NCT06340789

Disease control Sponsor: National Cheng-Kung University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether adding sodium benzoate—a substance that affects brain glutamate—to standard antipsychotic medication can improve symptoms and thinking in people with treatment-resistant schizophrenia. About 90 adults who have not responded well to at least two antipsychotics will receive either sodium benzoate or a placebo for 8 weeks. Researchers will use brain scans, blood tests, and symptom ratings to see if the treatment works and to identify who might benefit most.

What this could mean

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

Active substance
sodium benzoate
What this could lead to
If it works, this could offer a new add-on treatment option for people with schizophrenia who do not respond to standard antipsychotics.
What could go wrong
This is a Phase 2 trial with 90 participants, so results are still early. Sodium benzoate may not improve symptoms more than placebo, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

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

20 to 55 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: 1. Fulfil the DSM5 criteria for schizophrenia or schizoaffective disorder 2. Research criteria for treatment resistance: little or no symptomatic response to multiple (at least two) antipsychotic treatment of an adequate duration (at least 6 weeks) and adequate doses (equivalent to at least 600 milliequivalent (meq)/day of chlorpromazine) 3. 6 month period without remission (i.e. ≥4 item-score for the positive symptoms on PANSS scale , especially delusional thoughts, conceptual disorganisation, excitements, grandiosity, hallucinatory behaviour, excitement, persecution, and hostility) 4. The persistence of illness was defined as a score of ≥4 (moderately ill) on the severity of illness subscale of the Clinical Global Impression scale (CGI-S), and a lack of stable period of good social occupational function. Exclusion Criteria: 1. Current or previous diagnosis of concurrent DSM-5 disorder due to active medical problems, known neurological disease, or a contraindication to MRI scanning 2. Current diagnosis of substance-related disorder 3. Any acute or chronic medical condition 4. History of head trauma or neurological diseases.

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Conditions

The condition(s) this trial relates to.

Neurobehavioral Manifestations Psychotic Disorders schizoaffective disorder schizophrenia Schizophrenia, Treatment-Resistant treatment-refractory schizophrenia

As listed by the trial registrant

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

Schizo affective disorder Schizophrenia Symptom, cognitive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Taichung Veterans General Hospital Chiayi Branch

    RECRUITING

    Chiayi City, 600, Taiwan

More trials for these conditions

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