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Systematic Review

Sex Selection Bias in Schizophrenia Antipsychotic Trials—An Update Systematic Review

1
First Episode Psychosis Program, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), São Paulo 04017-030, Brazil
2
Interdisciplinary Laboratory in Clinical Neuroscience (LiNC), Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), São Paulo 04039-032, Brazil
*
Authors to whom correspondence should be addressed.
Academic Editor: Mary V. Seeman
Received: 1 March 2021 / Revised: 12 May 2021 / Accepted: 12 May 2021 / Published: 20 May 2021
(This article belongs to the Special Issue Psychosis in Women)
The lack of female participation in antipsychotic trials for schizophrenia poses an important issue regarding its applicability, with direct and real-life repercussions to clinical practice. Here, our aim is to systematically review the sampling sex bias among randomized clinical trials (RCTs) of second-generation antipsychotics—namely risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole—as an update to a previous 2005 review. We searched MEDLINE and the Cochrane database for studies published through 7 September 2020 that assessed adult samples of at least 50 subjects with a diagnosis of schizophrenia, schizophrenia spectrum disorder, or broad psychosis, in order to investigate the percentage of women recruited and associated factors. Our review included 148 RCTs, published from 1993 to 2020, encompassing 43,961 subjects. Overall, the mean proportion of women was 34%, but only 17 trials included 50% or more females. Younger samples, studies conducted in North America, pharmaceutical funding and presence of specific exclusion criteria for women (i.e., pregnancy, breast-feeding or lack of reliable contraceptive) were associated with a lower prevalence of women in the trials. Considering the possible different effects of antipsychotics in both sexes, and our lack of knowledge on the subject due to sampling bias, it is imperative to expand actions aimed at bridging this gap. View Full-Text
Keywords: second generation antipsychotics; clinical trials; schizophrenia; sex bias second generation antipsychotics; clinical trials; schizophrenia; sex bias
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MDPI and ACS Style

Fonseca, L.; Machado, V.; Luersen, Y.C.; Paraventi, F.; Doretto, L.; Chaves, A.C. Sex Selection Bias in Schizophrenia Antipsychotic Trials—An Update Systematic Review. Women 2021, 1, 97-108. https://0-doi-org.brum.beds.ac.uk/10.3390/women1020009

AMA Style

Fonseca L, Machado V, Luersen YC, Paraventi F, Doretto L, Chaves AC. Sex Selection Bias in Schizophrenia Antipsychotic Trials—An Update Systematic Review. Women. 2021; 1(2):97-108. https://0-doi-org.brum.beds.ac.uk/10.3390/women1020009

Chicago/Turabian Style

Fonseca, Lais, Viviane Machado, Yaskara C. Luersen, Felipe Paraventi, Larissa Doretto, and Ana C. Chaves 2021. "Sex Selection Bias in Schizophrenia Antipsychotic Trials—An Update Systematic Review" Women 1, no. 2: 97-108. https://0-doi-org.brum.beds.ac.uk/10.3390/women1020009

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