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However, like little is known about whether these drugs are effective and safe when compared in controlled and non-controlled settings. This study aims to assess the efficacy and safety of second-generation antipsychotics in ASD in randomised controlled trials (RCT) and observational studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This systematic review will include RCT and prospective cohorts evaluating second-generation antipsychotics in people 5\u2009years and older diagnosed with ASD. Searches will be conducted in Medline, Embase, Cochrane Library, Epistemonikos, Lilacs, CINAHL, PsycINFO, trial registries and grey literature databases without restriction on publication status, year of publication and language. The primary outcomes will be symptoms of aggressive behaviour, quality of life for the individual or their careers, and discontinuation or dropouts\/withdrawals of antipsychotics due to adverse events. The secondary outcomes are other not serious adverse events and adherence to pharmacotherapy. Selection, data extraction, and quality assessment will be performed by pairs of reviewers, independently. The Risk of Bias 2 (RoB 2) and Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tools will be used to assess the risk of bias in the included studies. If appropriate, a meta-analysis and network meta-analysis will be conducted to synthesise the results. The overall quality of the evidence for each outcome will be determined by the Recommendation, Assessment, Development and Evaluation approach.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study will systematically summarise the existing evidence evaluating the use of second-generation antipsychotics for treating ASD, in controlled and uncontrolled studies. The results of this review will be disseminated through peer-reviewed publications and conference presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PROSPERO registration number<\/jats:title>\n                    <jats:p>CRD42022353795.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-069114","type":"journal-article","created":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T13:15:41Z","timestamp":1687266941000},"page":"e069114","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Use of second-generation antipsychotics in autism spectrum disorder: a systematic review and meta-analysis protocol"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9186-110X","authenticated-orcid":false,"given":"Luis Phillipe Nagem","family":"Lopes","sequence":"first","affiliation":[{"name":"Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1178-2787","authenticated-orcid":false,"given":"Jardel Corr\u00eaa","family":"de Oliveira","sequence":"additional","affiliation":[{"name":"Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil"},{"name":"M\u00e9dico de Fam\u00edlia e Comunidade, Especialista em Sa\u00fade da Fam\u00edlia, Geriatria e Gerontologia, Secretaria Municipal de Sa\u00fade, Florianopolis, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristiane de C\u00e1ssia","family":"Bergamaschi","sequence":"additional","affiliation":[{"name":"Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Izabela","family":"Fulone","sequence":"additional","affiliation":[{"name":"Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisangela da Costa","family":"Lima","sequence":"additional","affiliation":[{"name":"Pharmacy School, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fl\u00e1via Casale","family":"Abe","sequence":"additional","affiliation":[{"name":"Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren Giustti","family":"Mazzei","sequence":"additional","affiliation":[{"name":"Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mabel Fernandes","family":"Figueir\u00f3","sequence":"additional","affiliation":[{"name":"Hospital do Cora\u00e7\u00e3o, Sao Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3684-3275","authenticated-orcid":false,"given":"Luciane Cruz","family":"Lopes","sequence":"additional","affiliation":[{"name":"Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,6,20]]},"reference":[{"key":"2025121407363892000_13.6.e069114.1","unstructured":"National Institute for Health and Care Excellence . 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