{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T14:34:57Z","timestamp":1791210897832,"version":"4.1.0"},"reference-count":23,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2023,4,18]],"date-time":"2023-04-18T00:00:00Z","timestamp":1681776000000},"content-version":"unspecified","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development, LLC","doi-asserted-by":"crossref","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Johnson and Johnson Global Public Health","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,3,23]]},"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the feasibility of conducting a large clinical trial within the Rwandan mental healthcare system that would establish the safety, efficacy and benefit of paliperidone palmitate once-monthly (PP1M) and once-every-3-months (PP3M) long-acting injectable formulations in adults with schizophrenia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Study design<\/jats:title>\n                  <jats:p>An open-label, prospective feasibility study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Setting\/Participants<\/jats:title>\n                  <jats:p>33 adult patients with schizophrenia were enrolled at 3 sites across Rwanda.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Interventions<\/jats:title>\n                  <jats:p>The study design included 3 phases of treatment: an oral run-in to establish tolerability to risperidone (1\u2009week), lead-in treatment with flexibly dosed PP1M to identify a stable dose (17 weeks) and maintenance treatment with PP3M (24 weeks).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Primary and secondary outcome measures<\/jats:title>\n                  <jats:p>Feasibility endpoints included compliance with governmental and institutional requirements, acceptable supply chain delivery and proper onsite administration of risperidone\/PP1M\/PP3M, adequate site infrastructure, adequate training of clinical staff and successful completion of study procedures and scales. A variety of study scales were administered to assess outcomes relevant to patients, caregivers, clinicians and payers in Rwanda and other resource-limited settings.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>This study was terminated early by the sponsor because certain aspects of study conduct needed to be addressed to maintain Good Clinical Practice requirements and meet regulatory standards. Results identified areas for improvement in study execution, including study governance, site infrastructure, study preparation and conduct of procedures, study budget and study assessments. Despite the identification of areas in need of adjustment, none of these limitations were considered insurmountable.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This work was designed to strengthen global research in schizophrenia by building the capacity of researchers to prepare and conduct pharmaceutical trials in resource-limited settings. Although the study was ended early, modifications motivated by the results will facilitate the successful design and completion of more comprehensive studies, including an ongoing, follow-up interventional trial of PP1M\/PP3M in a larger population of patients in Rwanda.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\" xlink:href=\"NCT03713658\">NCT03713658<\/jats:ext-link>\n                  <\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-064675","type":"journal-article","created":{"date-parts":[[2023,4,18]],"date-time":"2023-04-18T22:55:15Z","timestamp":1681858515000},"page":"e064675","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct03713658","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"given":"Larry","family":"Alphs","sequence":"first","affiliation":[{"name":"Janssen Scientific Affairs LLC, Titusville, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim","family":"Turkoz","sequence":"additional","affiliation":[{"name":"Janssen Research and Development, LLC, Titusville, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Smith-Swintosky","sequence":"additional","affiliation":[{"name":"Johnson & Johnson Services Inc, New Brunswick, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Keenan","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs LLC, Titusville, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Abraham","sequence":"additional","affiliation":[{"name":"Johnson & Johnson Services Inc, New Brunswick, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Schotte","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Belgium, Beerse, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eileen","family":"Hooker","sequence":"additional","affiliation":[{"name":"Janssen Research and Development, LLC, Titusville, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Damascene Iyamuremye","sequence":"additional","affiliation":[{"name":"Rwanda Biomedical Center, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvonne","family":"Kayiteshonga","sequence":"additional","affiliation":[{"name":"Rwanda Biomedical Center, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rutakayile","family":"Bizoza","sequence":"additional","affiliation":[{"name":"Ndera Neuropsychiatric Hospital, Ndera, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Branislav","family":"Mancevski","sequence":"additional","affiliation":[{"name":"Johnson & Johnson Services Inc, New Brunswick, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,4,18]]},"reference":[{"key":"2025101814341211000_13.4.e064675.1","doi-asserted-by":"crossref","first-page":"306","DOI":"10.4103\/0253-7176.108193","article-title":"Cultural aspects of major mental disorders: a critical review from an Indian perspective","volume":"34","author":"Viswanath","year":"2012","journal-title":"Indian J Psychol Med"},{"key":"2025101814341211000_13.4.e064675.2","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1111\/inr.12391","article-title":"Treatments for people living with schizophrenia in sub-Saharan Africa: an adapted realist review","volume":"65","author":"Chidarikire","year":"2018","journal-title":"Int Nurs Rev"},{"key":"2025101814341211000_13.4.e064675.3","doi-asserted-by":"crossref","first-page":"541","DOI":"10.1097\/JCP.0000000000001282","article-title":"Antipsychotic medication in sub-Saharan Africa: a systematic literature review","volume":"40","author":"Kumar","year":"2020","journal-title":"J Clin Psychopharmacol"},{"key":"2025101814341211000_13.4.e064675.4","doi-asserted-by":"crossref","DOI":"10.1016\/j.jval.2019.04.1058","article-title":"PMH13 estimating the benefit of long-acting injectables for schizophrenia treatment in Rwanda using a one-year cost-consequence model","volume":"22","author":"Thomas","year":"2019","journal-title":"Value in Health"},{"key":"2025101814341211000_13.4.e064675.5","unstructured":"Republic of Rwanda and Rwanda Biomedical Centre . 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