A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

NCT05622201 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 278825
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Immunological factors are assumed to be determinants for some psychiatric disorders, thus anti-inflammatory drugs may be helpful. However, studies on such treatments are scarce. An inflammatory modulating drug rituximab, cluster of differentiation antigen 20 antibodies (anti-CD20 antibodies), is a standard treatment for e.g. multiple sclerosis. The investigators aim to test rituximab in a randomised placebo-controlled double-blinded, add-on treatment trial in 120 participants (18-55 years) with schizophrenia spectrum disorder. Sampling from blood for analyses of inflammatory mediators are investigated at gene and protein levels and resting state functional magnetic resonance imaging (rsfMRI) and lumbar puncture are optional. Biomarkers will be investigated in relation to treatment response. Family member(s) to the patient and the patient (separate) will be asked to participate in a qualitative interview by an independent researcher after 3 months.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

RCT; immunomodulatory treatment; psychosis; rituximab; CD20 antibodies

Outcome Measures

Primary Outcomes (1)

• Proportion of responders to treatment, rated as much or very much improved with CGI-I

  Improvement according to clinical rated Clinical Global Impression-Improvement (CGI-I)

  Baseline up to week 12

Secondary Outcomes (13)

• Improvement in functioning

  Baseline up to week 12 and 24

• Change in psychotic symptoms

  Baseline up to 12 weeks

• Proportion of responders to treatment, rated as much or very much improved with CGI-I

  Baseline up to week 24

• Improvement since baseline

  Baseline up to week 12 and 24

• Change in severity since baseline

  Baseline up to week 12 and 24

Other Outcomes (3)

• Depression

  Baseline up to week 12 and 24

• Negative symptoms

  Baseline week 12 and week 24

• Qualitative assessment

  12-18 weeks after infusion

Study Arms (2)

Rituximab

EXPERIMENTAL

Rituximab 1000 mg, infusion

Drug: Rituximab

Placebo

PLACEBO COMPARATOR

Saline infusion

Drug: Rituximab

Interventions

Rituximab DRUG

Infusion

Also known as: Saline

Placebo; Rituximab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18 to 55 years
• duration of illness exceeding 1 year
• diagnosed with Schizophrenia spectrum disorder (SSD) according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• if female and with any risk for pregnancy, willing to use contraceptives or abstinence if normal and preferred lifestyle.
• participants should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
• insufficiently recovered from previous antipsychotic treatments.
• a minimum score of 4 (moderately ill) in Clinical global impression - severity (CGI-S) at baseline.

You may not qualify if:

• pregnancy or breast-feeding
• weight below 40 kg
• clinically relevant ongoing infection at the discretion of the physician
• chronic infections
• positive test for hepatitis B, hepatitis C, HIV, or tuberculosis
• current severe heart failure (NYHA grade IV) or any other severe heart disease (e.g. or history of cardiac arrhythmia or myocardial infarction)
• any change of antipsychotic medication within the previous 4 weeks
• unable to make an informed decision to consent to the trial
• ongoing clozapine treatment
• ongoing immunomodulatory treatment

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro university hospital

Örebro, Örebro County, 701 85, Sweden

Location

Related Publications (1)

• Bejerot S, Eklund D, Hesser H, Hietala MA, Kariis T, Lange N, Lebedev A, Montgomery S, Nordenskjold A, Petrovic P, Soderbergh A, Thunberg P, Wikstrom S, Humble MB; RCT-Rits study collaboration group. Study protocol for a randomized controlled trial with rituximab for psychotic disorder in adults (RCT-Rits). BMC Psychiatry. 2023 Oct 23;23(1):771. doi: 10.1186/s12888-023-05250-5.

  PMID: 37872497 DERIVED

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders

Interventions

Rituximab; Sodium Chloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Susanne Bejerot, MD, PhD

  Region Örebro län

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: informant, psychologist, laboratory staff
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A proof-of-concept study: a multicenter, placebo-controlled, double-blinded, add-on intervention study

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 18, 2022
• Study Start: March 21, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)