Jun Ishigooka, Kazuyuki Nakagome, Tetsuro Ohmori, Nakao Iwata, Ken Inada, Jun-Ichi Iga, Taro Kishi, Kiyoshi Fujita, Yuka Kikuchi, Toshiaki Shichijo, Hideaki Tabuse, Shotatsu Koretsune, Hiroshi Terada, Haruko Terada, Toshifumi Kishimoto, Yuichiro Tsutsumi, Kazutaka Ohi
{"title":"第二代抗精神病药物治疗精神分裂症的随机开放标签研究：JUMPs研究104周的最终结果，评估治疗中断、缓解和社会功能。","authors":"Jun Ishigooka, Kazuyuki Nakagome, Tetsuro Ohmori, Nakao Iwata, Ken Inada, Jun-Ichi Iga, Taro Kishi, Kiyoshi Fujita, Yuka Kikuchi, Toshiaki Shichijo, Hideaki Tabuse, Shotatsu Koretsune, Hiroshi Terada, Haruko Terada, Toshifumi Kishimoto, Yuichiro Tsutsumi, Kazutaka Ohi","doi":"10.1186/s12888-024-06031-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>We report the final results of treatment with aripiprazole, blonanserin, and paliperidone from the Japan Useful Medication Program for Schizophrenia (JUMPs), a 104-week naturalistic study.</p><p><strong>Methods: </strong>JUMPs was an open-label, three-arm, randomized, parallel-group, 104-week study. Patients aged ≥ 20 years with schizophrenia requiring antipsychotic treatment or a switch from previous therapy were enrolled. The primary endpoint was treatment discontinuation rate over 104 weeks. Secondary endpoints included remission rate, Personal and Social Performance (PSP), safety, Positive and Negative Syndrome Scale (PANSS), and quality of life (QOL; EuroQol-5 dimension).</p><p><strong>Results: </strong>In total, 251 patients received aripiprazole (n = 82), blonanserin (n = 85), or paliperidone (n = 84). Treatment discontinuation rates (aripiprazole, 80.5%; blonanserin, 81.2%; paliperidone, 71.4%) were not significantly different (p = 0.2385) among the treatment groups at 104 weeks; comparable outcomes were observed for endpoints, including remission (42.9%, 46.7%, and 45.8%), PANSS, and safety. In the overall cohort, while the improvement in the PSP total score at Week 104 was not significantly different from baseline, a significant improvement (p < 0.05) in QOL and total PANSS scores (including all subscales) was observed at Week 104 compared with baseline. Multivariable analysis identified a shorter disease duration and a higher chlorpromazine-equivalent antipsychotic dosage level (≥ 1000 mg) before switching to monotherapy as predictors of treatment discontinuation.</p><p><strong>Conclusions: </strong>The 104-week treatment outcomes were comparable between groups; the overall trend of improvement in remission rate, safety, and QOL suggests the importance of continued treatment.</p><p><strong>Clinical trial registration: </strong>UMIN-Clinical Trials Registry UMIN000007942 (public release date: 14/05/2012).</p>","PeriodicalId":9029,"journal":{"name":"BMC Psychiatry","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11376064/pdf/","citationCount":"0","resultStr":"{\"title\":\"Randomized open-label study of second-generation antipsychotics for the treatment of schizophrenia: 104-week final results of the JUMPs study assessing treatment discontinuation, remission, and social functioning.\",\"authors\":\"Jun Ishigooka, Kazuyuki Nakagome, Tetsuro Ohmori, Nakao Iwata, Ken Inada, Jun-Ichi Iga, Taro Kishi, Kiyoshi Fujita, Yuka Kikuchi, Toshiaki Shichijo, Hideaki Tabuse, Shotatsu Koretsune, Hiroshi Terada, Haruko Terada, Toshifumi Kishimoto, Yuichiro Tsutsumi, Kazutaka Ohi\",\"doi\":\"10.1186/s12888-024-06031-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>We report the final results of treatment with aripiprazole, blonanserin, and paliperidone from the Japan Useful Medication Program for Schizophrenia (JUMPs), a 104-week naturalistic study.</p><p><strong>Methods: </strong>JUMPs was an open-label, three-arm, randomized, parallel-group, 104-week study. Patients aged ≥ 20 years with schizophrenia requiring antipsychotic treatment or a switch from previous therapy were enrolled. The primary endpoint was treatment discontinuation rate over 104 weeks. Secondary endpoints included remission rate, Personal and Social Performance (PSP), safety, Positive and Negative Syndrome Scale (PANSS), and quality of life (QOL; EuroQol-5 dimension).</p><p><strong>Results: </strong>In total, 251 patients received aripiprazole (n = 82), blonanserin (n = 85), or paliperidone (n = 84). Treatment discontinuation rates (aripiprazole, 80.5%; blonanserin, 81.2%; paliperidone, 71.4%) were not significantly different (p = 0.2385) among the treatment groups at 104 weeks; comparable outcomes were observed for endpoints, including remission (42.9%, 46.7%, and 45.8%), PANSS, and safety. In the overall cohort, while the improvement in the PSP total score at Week 104 was not significantly different from baseline, a significant improvement (p < 0.05) in QOL and total PANSS scores (including all subscales) was observed at Week 104 compared with baseline. Multivariable analysis identified a shorter disease duration and a higher chlorpromazine-equivalent antipsychotic dosage level (≥ 1000 mg) before switching to monotherapy as predictors of treatment discontinuation.</p><p><strong>Conclusions: </strong>The 104-week treatment outcomes were comparable between groups; the overall trend of improvement in remission rate, safety, and QOL suggests the importance of continued treatment.</p><p><strong>Clinical trial registration: </strong>UMIN-Clinical Trials Registry UMIN000007942 (public release date: 14/05/2012).</p>\",\"PeriodicalId\":9029,\"journal\":{\"name\":\"BMC Psychiatry\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-09-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11376064/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Psychiatry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12888-024-06031-4\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12888-024-06031-4","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PSYCHIATRY","Score":null,"Total":0}
Randomized open-label study of second-generation antipsychotics for the treatment of schizophrenia: 104-week final results of the JUMPs study assessing treatment discontinuation, remission, and social functioning.
Background: We report the final results of treatment with aripiprazole, blonanserin, and paliperidone from the Japan Useful Medication Program for Schizophrenia (JUMPs), a 104-week naturalistic study.
Methods: JUMPs was an open-label, three-arm, randomized, parallel-group, 104-week study. Patients aged ≥ 20 years with schizophrenia requiring antipsychotic treatment or a switch from previous therapy were enrolled. The primary endpoint was treatment discontinuation rate over 104 weeks. Secondary endpoints included remission rate, Personal and Social Performance (PSP), safety, Positive and Negative Syndrome Scale (PANSS), and quality of life (QOL; EuroQol-5 dimension).
Results: In total, 251 patients received aripiprazole (n = 82), blonanserin (n = 85), or paliperidone (n = 84). Treatment discontinuation rates (aripiprazole, 80.5%; blonanserin, 81.2%; paliperidone, 71.4%) were not significantly different (p = 0.2385) among the treatment groups at 104 weeks; comparable outcomes were observed for endpoints, including remission (42.9%, 46.7%, and 45.8%), PANSS, and safety. In the overall cohort, while the improvement in the PSP total score at Week 104 was not significantly different from baseline, a significant improvement (p < 0.05) in QOL and total PANSS scores (including all subscales) was observed at Week 104 compared with baseline. Multivariable analysis identified a shorter disease duration and a higher chlorpromazine-equivalent antipsychotic dosage level (≥ 1000 mg) before switching to monotherapy as predictors of treatment discontinuation.
Conclusions: The 104-week treatment outcomes were comparable between groups; the overall trend of improvement in remission rate, safety, and QOL suggests the importance of continued treatment.
期刊介绍：
BMC Psychiatry is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of psychiatric disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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