Study protocol for a randomized controlled trial with rituximab for psychotic disorder in adults (RCT-Rits)

↓ Direkt till sidans innehåll
↓ Direkt till sidans sekundära innehåll (sidomenyn)

Search: onr:"swepub:oai:DiVA.org:oru-109377" > Study protocol for ...

1 of 1
Previous record
Next record
To hitlist

Study protocol for a randomized controlled trial with rituximab for psychotic disorder in adults (RCT-Rits)

Bejerot, Susanne, 1955- (author): Örebro universitet,Institutionen för medicinska vetenskaper,Faculty of Health and Medical Sciences, University Health Care Research Centre, Örebro University, Örebro, Sweden

Eklund, Daniel, 1984- (author): Örebro universitet,Institutionen för medicinska vetenskaper

Hesser, Hugo, 1982- (author): Örebro universitet,Institutionen för beteende-, social- och rättsvetenskap

Hietala, Max Albert (author): Department of Neurology, Karolinska University Hospital, Stockholm, Sweden

Kariis, Tarmo (author): Karlstad Central Hospital, Region Värmland, Karlstad, Sweden

Lange, Niclas, 1990- (author): Örebro universitet,Institutionen för medicinska vetenskaper

Lebedev, Alexander (author): Center for Psychiatry Research (CPF), Center for Cognitive and Computational Neuropsychiatry (CCNP), Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

Montgomery, Scott, 1961- (author): Örebro universitet,Institutionen för medicinska vetenskaper,Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

Nordenskjöld, Axel, 1977- (author): Örebro universitet,Institutionen för medicinska vetenskaper

Petrovic, Predrag (author): Center for Psychiatry Research (CPF), Center for Cognitive and Computational Neuropsychiatry (CCNP), Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden

Söderbergh, Annika (author): Department of Rheumatology, Örebro University Hospital, Örebro, Sweden

Thunberg, Per, 1968- (author): Örebro universitet,Institutionen för medicinska vetenskaper,Department of Radiology and Medical Physics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Center for Experimental and Biomedical Imaging in Örebro (CEBIO), Faculty of Medicine and Health, Örebro University, Örebro, Sweden

Wikström, Sverre, 1978- (author): Örebro universitet,Institutionen för medicinska vetenskaper,Centre for Clinical Research, County Council of Värmland, Karlstad, Sweden

Humble, Mats B., 1952- (author): Örebro universitet,Institutionen för medicinska vetenskaper

show less...

(creator_code:org_t)

BioMed Central (BMC), 2023
2023
English.
In: BMC Psychiatry. - : BioMed Central (BMC). - 1471-244X. ; 23:1

Related links:: https://doi.org/10.1...; show more...; https://urn.kb.se/re...; https://doi.org/10.1...; http://kipublication...; http://kipublication...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

BACKGROUND: The role of inflammation in the aetiology of schizophrenia has gained wide attention and research on the association shows an exponential growth in the last 15 years. Autoimmune diseases and severe infections are risk factors for the later development of schizophrenia, elevated inflammatory markers in childhood or adolescence are associated with a greater risk of schizophrenia in adulthood, individuals with schizophrenia have increased levels of pro-inflammatory cytokines compared to healthy controls, and autoimmune diseases are overrepresented in schizophrenia. However, treatments with anti-inflammatory agents are so far of doubtful clinical relevance. The primary objective of this study is to test whether the monoclonal antibody rituximab, directed against the B-cell antigen CD20 ameliorates psychotic symptoms in adults with schizophrenia or schizoaffective disorder and to examine potential mechanisms. A secondary objective is to examine characteristics of inflammation-associated psychosis and to identify pre-treatment biochemical characteristics of rituximab responders. A third objective is to interview a subset of patients and informants on their experiences of the trial to obtain insights that rating scales may not capture.METHODS: A proof-of-concept study employing a randomised, parallel-group, double-blind, placebo-controlled design testing the effect of B-cell depletion in patients with psychosis. 120 participants with a diagnosis of schizophrenia spectrum disorders (SSD) (ICD-10 codes F20, F25) will receive either one intravenous infusion of rituximab (1000 mg) or saline. Psychiatric measures and blood samples will be collected at baseline, week 12, and week 24 post-infusion. Brief assessments will also be made in weeks 2 and 7. Neuroimaging and lumbar puncture, both optional, will be performed at baseline and endpoints. Approximately 40 of the patients and their informants will be interviewed for qualitative analyses on the perceived changes in well-being and emotional qualities, in addition to their views on the research.DISCUSSION: This is the first RCT investigating add-on treatment with rituximab in unselected SSD patients. If the treatment is helpful, it may transform the treatment of patients with psychotic disorders. It may also heighten the awareness of immune-psychiatric disorders and reduce stigma.TRIAL REGISTRATION: NCT05622201, EudraCT-nr 2022-000220-37 version 2.1. registered 14th of October 2022.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Psykiatri (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Psychiatry (hsv//eng)

Keyword

Clinical trials
Immunology
Inflammation
Magnetic resonance imaging
Monoclonal antibodies
Schizophrenia & psychotic disorders

Publication and Content Type

ref (subject category)
art (subject category)

Find in a library

BMC Psychiatry (Search for host publication in LIBRIS)

To the university's database

1 of 1
Previous record
Next record
To hitlist

Find more in SwePub

By the author/editor: Bejerot, Susanne ...; Eklund, Daniel, ...; Hesser, Hugo, 19 ...; Hietala, Max Alb ...; Kariis, Tarmo; Lange, Niclas, 1 ...; show more...; Lebedev, Alexand ...; Montgomery, Scot ...; Nordenskjöld, Ax ...; Petrovic, Predra ...; Söderbergh, Anni ...; Thunberg, Per, 1 ...; Wikström, Sverre ...; Humble, Mats B., ...; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Psychiatry

Articles in the publication: BMC Psychiatry

By the university: Örebro University; Karolinska Institutet

Search outside SwePub

Extend your search to:: Google; Google Book Search; Google Scholar

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

LIBRIS.kb.se