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.

IF 3.4 2区 医学 Q2 PSYCHIATRY BMC Psychiatry Pub Date : 2024-09-05 DOI:10.1186/s12888-024-06031-4
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
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Abstract

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.

Clinical trial registration: UMIN-Clinical Trials Registry UMIN000007942 (public release date: 14/05/2012).

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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。
背景:我们报告了一项为期104周的自然研究--日本精神分裂症有效药物治疗项目(JUMPs)--中阿立哌唑、布洛南色林和帕利哌酮治疗的最终结果:JUMPs是一项为期104周的开放标签、三臂、随机、平行分组研究。研究对象为年龄≥ 20 岁、需要接受抗精神病治疗或从以前的治疗中转换过来的精神分裂症患者。主要终点是104周的治疗中断率。次要终点包括缓解率、个人和社会表现(PSP)、安全性、阳性和阴性综合征量表(PANSS)以及生活质量(QOL;EuroQol-5维度):共有251名患者接受了阿立哌唑(82人)、布洛南色林(85人)或帕利哌酮(84人)治疗。在104周时,各治疗组的治疗中止率(阿立哌唑,80.5%;布洛南舍林,81.2%;帕利哌酮,71.4%)无显著差异(p = 0.2385);在终点(包括缓解率(42.9%、46.7%和45.8%)、PANSS和安全性)方面观察到的结果具有可比性。在总体队列中,虽然第104周时PSP总分的改善与基线相比无显著差异,但第104周时PSP总分的显著改善(p 结论:PSP总分的改善与基线相比无显著差异)与第104周时PSP总分的显著改善(p 结论:PSP总分的改善与基线相比无显著差异)之间具有可比性:104周的治疗结果在各组之间具有可比性;缓解率、安全性和 QOL 的总体改善趋势表明了继续治疗的重要性:临床试验注册:UMIN-Clinical Trials Registry UMIN000007942(公开发布日期:14/05/2012)。
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来源期刊
BMC Psychiatry
BMC Psychiatry 医学-精神病学
CiteScore
5.90
自引率
4.50%
发文量
716
审稿时长
3-6 weeks
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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