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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一项针对 1021 名服用氯氮平的澳大利亚人的全国研究中的氯氮平疗效和药物不良反应：ClozaGene 研究


背景和假设 ClozaGene 研究是一个全国性的接受氯氮平治疗的成年人队列。虽然氯氮平可用于治疗难治性精神分裂症，但它与相当大的药物不良反应 （ADR） 负担有关，并且并非所有患者都能获得足够的症状反应。目前的研究侧重于自我报告的氯氮平使用和反应、氯氮平相关 ADR 和心理健康合并症的经历。研究设计 共有 1021 名参与者 （41.0% 为女性;年龄 46.2 ± 10.6 岁 [范围 18-66]）通过基于氯氮平处方的邮寄方式招募。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% 报告终生诊断为抑郁症，15.6% 为双相情感障碍，8.1% 为分裂情感障碍。氯氮平目前开给 944 名 （92.5%） 参与者，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 3/4 的精神分裂症参与者报告说，氯氮平有助于中度到非常好地控制他们的精神分裂症症状。最常报告的 ADR 是流涎 （80.3%） 、体重增加 （71.0%） 、便秘 （56.9%） 和镇静 （52.8%）。氯氮平诱导的心肌炎和中性粒细胞减少症导致氯氮平停止的患病率分别为 1% 和 0.4%。结论 我们的研究结果强调了澳大利亚普通人群中服用氯氮平的成年人的精神病和代谢症状以及 ADRs 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。