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Could an arthritis drug help treat schizophrenia?

NCT ID NCT05622201

Disease control Sponsor: Region Örebro County 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether rituximab, an anti-inflammatory drug used for conditions like multiple sclerosis, can improve symptoms in adults with schizophrenia spectrum disorders. About 123 participants aged 18-55 will receive rituximab or a placebo added to their usual treatment. The study also looks at blood markers and brain scans to understand who might benefit.

What this could mean

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

Active substance
rituximab
What this could lead to
If it works, this could point toward a new treatment option for some people with schizophrenia by targeting inflammation.
What could go wrong
This is a small, early-phase trial. Rituximab is not proven for psychosis, and results may not apply to everyone. Side effects from immune suppression 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

123 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Dec 2026

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

18 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. ages 18 to 55 years 2. duration of illness exceeding 1 year 3. diagnosed with Schizophrenia spectrum disorder (SSD) according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 4. if female and with any risk for pregnancy, willing to use contraceptives or abstinence if normal and preferred lifestyle. 5. participants should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent. 6. insufficiently recovered from previous antipsychotic treatments. 7. a minimum score of 4 (moderately ill) in Clinical global impression - severity (CGI-S) at baseline. Exclusion Criteria: 1. pregnancy or breast-feeding 2. weight below 40 kg 3. clinically relevant ongoing infection at the discretion of the physician 4. chronic infections 5. positive test for hepatitis B, hepatitis C, HIV, or tuberculosis 6. malignancy currently or within 2 years prior to inclusion 7. current severe heart failure (NYHA grade IV) or any other severe heart disease (e.g. or history of cardiac arrhythmia or myocardial infarction) 8. any change of antipsychotic medication within the previous 4 weeks 9. unable to make an informed decision to consent to the trial 10. ongoing clozapine treatment 11. ongoing immunomodulatory treatment 12. treatments with monoclonal antibodies within 1 year before the inclusion

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Conditions

The condition(s) this trial relates to.

psychotic disorder Psychotic Disorders schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

As listed by the trial registrant

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

Schizophrenia spectrum and other psychotic disorders

Contacts and locations

Locations

  • Örebro university hospital

    Örebro, Örebro County, 701 85, Sweden

More trials for these conditions

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