Background and Hypothesis The ClozaGene Study is a nationwide cohort of adults who have been treated with clozapine. While clozapine is indicated in the management of treatment-resistant schizophrenia, it is associated with a considerable adverse drug reaction (ADR) burden, and not all patients achieve adequate symptomatic response. The current study focuses on self-reported experiences of clozapine use and response, clozapine-associated ADRs, and mental health comorbidity. Study Design A total of 1021 participants (41.0% female; aged 46.2 ± 10.6 years [range 18–66]) were recruited via a mail-out based on prescriptions for clozapine. Participants completed a self-report questionnaire. Study Results Most participants (90.1%, n = 912) were living with schizophrenia while 41.5% reported a lifetime diagnosis of depression, 15.6% bipolar disorder, and 8.1% schizoaffective disorder. Clozapine was currently prescribed to 944 (92.5%) participants and 37.8% of these participants self-reported currently taking additional antipsychotic medication. Nearly 3 quarters of participants living with schizophrenia reported that clozapine helped control their schizophrenia symptoms moderately to very well. The most commonly reported ADRs were sialorrhea (80.3%), weight gain (71.0%), constipation (56.9%), and sedation (52.8%). The prevalence of clozapine cessation due to clozapine-induced myocarditis and neutropenia was 1% and 0.4%, respectively. Conclusions Our findings highlight the high rate of psychotic and metabolic symptoms and ADRs among adults prescribed clozapine in the general Australian population. Future genomic analyses will focus on identifying genetic variants influencing clozapine treatment response and side effects.

中文翻译：

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对 1021 名服用氯氮平的澳大利亚人进行的全国性研究中氯氮平的疗效和药物不良反应：ClozaGene 研究

背景和假设 ClozaGene 研究是一项全国性的接受氯氮平治疗的成年人队列。虽然氯氮平适用于治疗难治性精神分裂症，但它会带来相当大的药物不良反应 (ADR) 负担，而且并非所有患者都能获得足够的症状反应。目前的研究重点是自我报告的氯氮平使用经验和反应、氯氮平相关的不良反应以及心理健康合并症。研究设计 根据氯氮平处方，通过邮寄方式招募了总共 1021 名参与者（41.0% 为女性；年龄 46.2 ± 10.6 岁 [范围 18-66]）。参与者完成了一份自我报告问卷。研究结果 大多数参与者（90.1%，n = 912）患有精神分裂症，而 41.5% 的人终生诊断为抑郁症，15.6% 的人患有双相情感障碍，8.1% 的人患有分裂情感障碍。目前有 944 名 (92.5%) 参与者服用了氯氮平，其中 37.8% 的参与者自我报告目前正在服用额外的抗精神病药物。近四分之三的精神分裂症患者表示，氯氮平有助于中等到很好地控制他们的精神分裂症症状。最常见的不良反应是流涎（80.3%）、体重增加（71.0%）、便秘（56.9%）和镇静（52.8%）。因氯氮平诱发的心肌炎和中性粒细胞减少症而停用氯氮平的患病率分别为 1% 和 0.4%。结论 我们的研究结果强调了在澳大利亚普通人群中服用氯氮平的成年人中精神病和代谢症状以及不良反应的发生率很高。未来的基因组分析将侧重于识别影响氯氮平治疗反应和副作用的遗传变异。