ArticleF1000Research2025
Sex differences in the efficacy and tolerability of antipsychotic drugs in people with an acute exacerbation of schizophrenia: protocol for an individual-participant-data, dose-response, network meta-analysis.
Article in F1000Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: There are currently no sex-specific recommendations for antipsychotic prescribing in schizophrenia, although women may be more susceptible to certain side-effects and may require lower doses to achieve comparable efficacy to men. However, sex differences remain insufficiently studied to inform treatment decisions. Methods: We plan a systematic review and individual-participant-data meta-analysis of randomized trials comparing different antipsychotic drugs, doses, formulations with each other or with placebo in adults with acute schizophrenia. Eligible studies will be identified through the Vivli platform, and their individual-participant-data will be harmonized into a common dataset. Two independent reviewers will screen search results and assess risk of bias using the Risk of Bias 2 tool. The primary outcome will be overall symptoms of schizophrenia, and secondary outcomes will include a broad range of efficacy, tolerability, acceptability, and dosing measures.A stepwise approach to data synthesis will be adopted, depending on individual-participant-data availability, aiming to examine sex differences in the effects of antipsychotic drugs compared to placebo. If sufficient data are available, we will conduct random-effects meta-analyses using regression models to evaluate biological sex, typically categorised as male or female, as both a prognostic factor and an effect modifier, network meta-analyses to synthesize direct and indirect evidence, and dose-response meta-analyses using restricted cubic splines to explore dose-effect relationships. The robustness of the findings will be assessed through sensitivity analyses adjusting for additional covariates.The certainty of evidence on sex differences will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for subgroup analysis. If the certainty is judged to be moderate or high, sex-specific treatment effects will be further assessed using the Confidence in Network Meta-Analysis (CINeMA) framework. Discussion: This study will examine sex differences in the efficacy, tolerability, and dosing of antipsychotics in acute schizophrenia, potentially contributing to evidence-based, sex-specific treatment recommendations for antipsychotic prescribing.
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