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Efficacy and Safety of Ondansetron in Schizophrenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Published online by Cambridge University Press:  20 June 2025

Omar Kassar ,
Osama Hassan ,
Omar Shaheen ,
Abdullah Selim  and
Moaz Elsayed Abouelmagd
Omar Kassar
Affiliation:
1Faculty of Medicine, Alexandria University, Alexandria, Egypt 2Medical Research Group of Egypt, Neida Academy, Arlington, Massachusetts, USA
Osama Hassan
Affiliation:
3Central and North West London NHS Foundation Trust, London, United Kingdom 4Faculty of Medicine, Zagazig University, Zagazig, Egypt
Omar Shaheen
Affiliation:
1Faculty of Medicine, Alexandria University, Alexandria, Egypt
Abdullah Selim
Affiliation:
1Faculty of Medicine, Alexandria University, Alexandria, Egypt
Moaz Elsayed Abouelmagd
Affiliation:
5Faculty of Medicine, Cairo University, Cairo, Egypt
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Abstract

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Aims: It has been shown that 5-hydroxytryptamine3 (5-HT3) receptors are involved in the pathogenesis of schizophrenia. This systematic review and meta-analysis of randomized clinical trials (RCTs) evaluates the efficacy and safety of ondansetron, a potent 5-HT3 receptor antagonist, as adjunctive treatment for the management of schizophrenia, especially the negative symptoms and cognitive deficits.

Methods: A comprehensive search of electronic databases, including PubMed, Scopus, Cochrane, and Web of Science, was performed in October 2024. We included only randomized controlled trials (RCTs), and their data were extracted and analysed using RevMan 5.4 software. The primary outcome was the PANSS (Positive and Negative Syndrome Scale) negative subscale.

Results: Eight RCTs involving 533 patients were included in the study. Ondansetron showed a statistically significant improvement in PANSS negative subscale at 12 weeks [pooled as mean difference, MD=−2.96, 95% CI [−4.69, −1.24], p=0.00007] and in general psychopathology scale [MD= −2.71, 95% CI [−3.52, −1.90]] compared with placebo. However, ondansetron and placebo did not differ in reduction of PANSS positive subscale [MD= 0.1, 95% CI [−1.19, 1.38], p=0.88], and depression scale (SMD= 0.71, 95% [−0.35, 1.77], p=0.19). Ondansetron showed no significant difference regarding tardive dyskinesia between the two groups. However, constipation was significant in the ondansetron group over placebo.

Conclusion: The study’s findings support the use of ondansetron as adjuvant therapy in the management of schizophrenia, particularly the negative symptoms and cognitive deficits.

Type
Research
Information
BJPsych Open , Volume 11 , Supplement S1: Abstracts from the RCPsych International Congress 2025, 23–26 June , June 2025 , pp. S38
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Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of Royal College of Psychiatrists

Footnotes

Abstracts were reviewed by the RCPsych Academic Faculty rather than by the standard BJPsych Open peer review process and should not be quoted as peer-reviewed by BJPsych Open in any subsequent publication.

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