阿立哌唑和利培酮治疗首发非情感性精神病的疗效比较:一项前瞻性、随机、3期、研究者启动的研究(PAFIP-3)的基本原理和设计

IF 5.2 3区 医学 Q1 PSYCHIATRY
Mayoral-van Son J. , Marcos Gómez-Revuelta , Rosa Ayesa-Arriola , Javier Vázquez-Bourgón , Víctor Ortiz-García de la Foz , Miguel Ruiz-Veguilla , Nathalia Garrido , Diana Tordesillas-Gutiérrez , Esther Setién-Suero , Benedicto Crespo-Facorro
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引用次数: 11

摘要

背景:选择最有效的治疗方法是一项关键的挑战,有可能改变初次精神病发作患者的长期预后。比较抗精神病药物对首发非情感性精神病(FEP)个体疗效的正面临床试验很少。方法报告一项三期临床试验(PAFIP-3, NCT02305823)的基本原理和设计,比较阿立哌唑和利培酮的有效性,并评估早期使用氯氮平对原发性治疗耐药患者的益处。该设计包括5个工作包(药物算法、认知功能、心理教育/职业功能、成像和生物标记),解决首发精神病患者及其护理的关键问题和需求。主要结局指标是通过全因治疗停药率评估治疗效果。结果266人被纳入随机化研究I期(利培酮vs阿立哌唑)。在3个月时,保留率为94%(249/266),48例(19.3%)患者通过了II期(奥氮平治疗),7例(2.8%)患者进入氯氮平期(III期)。讨论PAFIP 3临床试验可能为临床指南提供相关信息,以最佳地治疗首次发作的非情感性精神病患者,以及早期使用氯氮平治疗耐药患者的益处和风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of aripiprazole and risperidone effectiveness in first episode non-affective psychosis: Rationale and design of a prospective, randomized, 3-phase, investigator-initiated study (PAFIP-3)

Background

Selecting the most effective treatment represents a critical challenge with the potential of modifying the long-term prognosis of individuals suffering a first break of psychosis. Head-to-head clinical trials comparing effectiveness among antipsychotic drugs in individuals with a first-episode of non-affective psychosis (FEP) are scarce.

Methods

The rationale and design of a 3 phases clinical trial (PAFIP-3, NCT02305823) comparing the effectiveness of aripiprazole and risperidone, and to additionally assess the benefits of an early use of clozapine in primary treatment-resistant patients is reported. The design encompasses of 5 work packages (medication algorithm, cognitive functioning, psychoeducation/vocational functioning, imaging and biological markers) addressing critical issues and needs of first episode psychosis individuals and their cares. The primary outcome measure was treatment effectiveness assessed by all-cause treatment discontinuation rate.

Results

266 individuals have been included in the randomization study phase I (risperidone vs. aripiprazole). At 3 months, the retention rate was of 94% (249/266), 48(19.3%) patients have gone through phase II (olanzapine treatment), and 7(2.8%) entered the clozapine phase (phase III).

Discussion

The PAFIP 3 clinical trial may provide relevant information about clinical guidelines to optimally treat patients with a first episode of non-affective psychosis and the benefits and risks of an early use of clozapine in treatment resistant patients.

Clinicaltrials.gov: NCT02305823.

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来源期刊
自引率
3.30%
发文量
58
期刊介绍: The Spanish Journal of Psychiatry and Mental Health (SJPMH), incorporated into ISSN 1888-9891, is the official scientific publication of the Spanish Society of Psychiatry and Mental Health. The journal focuses on studying mental illnesses, their pathological processes, and their psychosocial consequences, and aims to disseminate scientific advances in all areas related to mental health and illness. SJPMH accepts unpublished works on psychiatry and mental health, including their medical and social implications. The journal provides space for research in the biological, clinical, and psychosocial fields. Manuscripts undergo peer-review by external reviewers before being accepted for publication. SJPMH is indexed in Index Medicus/Medline, IBECS, Social Sciences Citation Index Journal Citation Reports/Social Sciences Edition, and Current Contents/Social and Behavioral Sciences.
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