Randomised controlled trial of clozapine in resistant schizophrenia and schizoaffective disorder.

IF 5.5 3区 医学 Q1 CLINICAL NEUROLOGY
Marc Peraire, Francisco Arnau-Peiró, Mariano Villar-García, Ana Benito, Iván Echeverria, Gonzalo Haro
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引用次数: 0

Abstract

Background: Clozapine (CLZ) stands out for its unique receptor profile, making it more effective than other antipsychotics, especially in treatment-resistant schizophrenia (TRS). There is growing evidence supporting its use in schizoaffective disorder (SZD), although diagnostic challenges and drug characteristics have complicated the implementation of specific clinical trials.

Aim: Compare efficacy and tolerability of CLZ in real-world patients with TRS and SZD.

Methods: Prospective, pragmatic, three-month, evaluator-blinded clinical trial with two randomised controlled arms (TRS groups) and a third fixed arm (SZD group). The clinical response was assessed by monthly visits during which the Positive and Negative Syndrome Scale (PANSS), Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Rating Scale (MADRS), Calgary Depression Scale for Schizophrenia (CDSS), Clinical Global Impression (CGI) and Udvalg für Kliniske Undersogelser were administered. One hundred twenty-seven participants (74.8% men, 25.2% women; 84 TRS, 42 SZD; mean age of 38.53) completed the follow-up.

Results: Patients treated with CLZ showed a greater reduction in all the PANSS subscales, MADRS and CDSS. In cases of SZD, there was a significant decrease in positive (F: 3.72, p < 0.05) and negative (F: 6.58, p < 0.01) symptoms, the overall score of PANSS (F: 5.64, p < 0.01) and YMRS (F: 12.01, p < 0.01). Patients using CLZ had a better subjective perception of their treatment (χ2: 17.29, p < 0.01). CLZ prescription was the only predictor of better outcomes across all the scales and improved substance use (dual disorders).

Conclusions: CLZ was effective in reducing psychotic and affective symptoms in patients with dual psychosis, with better outcomes in SZD compared with TRS.EudraCT protocol trial:2021-001278-44 (Comparative analysis of the effectiveness of clozapine in resistant schizophrenia and schizoaffective disorder; clinicaltrialsregister.eu/ctr-search/trial/2021-001278-44/ES).

氯氮平治疗顽固性精神分裂症和分裂情感性障碍的随机对照试验。
背景:氯氮平(CLZ)因其独特的受体谱而引人注目,使其比其他抗精神病药物更有效,特别是在治疗难治性精神分裂症(TRS)中。越来越多的证据支持其用于精神分裂情感障碍(SZD),尽管诊断挑战和药物特性使具体临床试验的实施复杂化。目的:比较CLZ在现实生活中TRS和SZD患者的疗效和耐受性。方法:前瞻性、实用性、评估者盲法临床试验,2个随机对照组(TRS组)和1个固定组(SZD组)。临床反应通过每月访问进行评估,期间使用阳性和阴性综合征量表(PANSS)、青年躁狂症评定量表(YMRS)、Montgomery-Asberg抑郁评定量表(MADRS)、卡尔加里精神分裂症抑郁量表(CDSS)、临床总体印象量表(CGI)和Udvalg f r Kliniske Undersogelser。127名参与者(男性74.8%,女性25.2%;84吨,42吨;平均年龄38.53岁)完成随访。结果:经CLZ治疗的患者PANSS各亚量表、MADRS和CDSS均有明显降低。在SZD病例中,CLZ阳性显著降低(F: 3.72, p: 6.58, p: 5.64, p: 12.01, p: 17.29, p)。结论:CLZ可有效减轻双重精神病患者的精神病性和情感性症状,SZD治疗效果优于TRS。氯氮平治疗顽固性精神分裂症和分裂情感性障碍疗效的比较分析;clinicaltrialsregister.eu / ctr-search /试验/ 2021-001278-44 / ES)。
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来源期刊
Journal of Psychopharmacology
Journal of Psychopharmacology 医学-精神病学
CiteScore
8.60
自引率
4.90%
发文量
126
审稿时长
3-8 weeks
期刊介绍: The Journal of Psychopharmacology is a fully peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology. The journal provides an essential forum for researchers and practicing clinicians on the effects of drugs on animal and human behavior, and the mechanisms underlying these effects. The Journal of Psychopharmacology is truly international in scope and readership.
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