Rituximab for Schizophrenia Spectrum Disorder (RITS-PS-2019)

NCT03983018 | Completed Phase 2 Results

• 1 other identifier: EudraCT Number: 2018-004618-17
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant schizophrenia spectrum disorder in an open trial.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Treatment-resistant Schizophrenia

Keywords

Immunopsychiatry; Schizophrenia spectrum disorder; treatment-resistant

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  Change in symptoms measured as change in Positive and Negative Syndrome Scale (PANSS) score from baseline. PANSS measures symptom severity of patients with schizophrenia and is a clinically based interview. PANSS measures positive symptoms (7 items, range 7-49), which refer to e.g. hallucinations and delusions; negative symptoms (e.g. loss of normal functions) (7 items, range 1-7) and general disability (16 Items, range 16 -112) separately. Higher scores denote more symptoms and disability. PANSS total score range from 30-210. At least 40 % reduction in PANSS total score is regarded as response.

  week 20

Secondary Outcomes (6)

• Personal and Social Performance Scale (PSP)

  week 20

• Clinical Global Impression-Severity (CGI-S) Scale

  week 20

• Clinical Global Impression-Improvement (CGI-I) in Relation to Inflammatory Markers

  week 20

• Clinical Global Impression-Improvement (CGI-I). Proportion of Responders.

  week 20

• Clinical Global Impression-Improvement (CGI-I).

  week 20

Other Outcomes (9)

• Positive and Negative Syndrome Scale (PANSS)

  week 40

• Personal and Social Performance Scale (PSP)

  week 40

• Clinical Global Impression-Severity (CGI-S) Scale

  week 40

Study Arms (1)

Rituximab

EXPERIMENTAL

1000 mg of rituximab, infusion once

Drug: Rituximab

Interventions

Rituximab DRUG

Infusion

Rituximab

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patient ages 18 to 40 years
• a duration of illness exceeding 2 years
• correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S)
• Global Assessment of Functioning below 50
• Schizophrenia spectrum disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• treatment resistance, i.e. failing to remit despite adequate treatments
• if female and with any risk for pregnancy, willing to use contraceptives
• if antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within therapeutic interval.
• subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
• immunoglobulin levels within the normal range

You may not qualify if:

• on-going immunomodulatory treatment
• pregnancy or breast-feeding
• weight below 40 kg
• clinically relevant on-going infection
• chronic infections
• positive screening test for hepatitis B, C, HIV or tuberculosis
• any change of psychotropic medication within the previous 4 weeks
• "much" or "very much improved" already at baseline according to CGI-I i.e. scores of 1 or 2 by the clinician
• severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
• unable to make an informed decision to consent to the trial
• in compulsory treatment
• treatment with clozapine within the last 2 months
• previous treatments with immunosuppressive agents

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator

Study Sites (1)

Region Örebro Län

Örebro, 70116, Sweden

Location

Related Publications (2)

• Bejerot S, Sigra Stein S, Welin E, Eklund D, Hylen U, Humble MB. Rituximab as an adjunctive treatment for schizophrenia spectrum disorder or obsessive-compulsive disorder: Two open-label pilot studies on treatment-resistant patients. J Psychiatr Res. 2023 Feb;158:319-329. doi: 10.1016/j.jpsychires.2022.12.003. Epub 2022 Dec 20.

  PMID: 36638622 RESULT

• Thunberg P, Fresnais D, Hamilton P, Bejerot S, Humble MB. Immunomodulatory treatment may change functional and structural brain imaging in severe mental disorders. Brain Behav Immun Health. 2024 Sep 16;41:100864. doi: 10.1016/j.bbih.2024.100864. eCollection 2024 Nov.

  PMID: 39350952 RESULT

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia, Treatment-Resistant

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Mental Disorders; Schizophrenia

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Prof Susanne Bejerot
• Organization: Örebro University

susanne.bejerot@oru.se

+46701655102

Study Officials

• Susanne Bejerot

  Region Orebro lan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: open trial

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 12, 2019
• Study Start: August 7, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)