Clinical Dataset of the CYP-GUIDES Trial

CYP-GUIDES (Cytochrome Psychotropic Genotyping Under Investigation for Decision Support) is a randomized controlled trial (RCT) comparing 2 outcomes in hospitalized patients with severe depressive disorders treated according to the patient's CYP2D6 genotype and functional status versus standard psychotropic therapy. The primary outcome was hospital Length of Stay (LOS) and the secondary outcome was the Re-Admission Rate (RAR) 30 days after discharge.

The trial setting was the Institute of Living at Hartford Hospital. CYP2D6 genotyping was implemented to characterize the functional status of the CYP2D6 enzyme with sub-normal, normal or supra-normal function. The electronic medical record (EMR) was utilized to transmit clinically actionable drug prescribing guidance based on the patient's CYP2D6 function to the physician.

The RCT recruited 1500 patients, genotyped CYP2D6 in 1459, and randomized 477 to standard therapy (Group S), for whom treatment-as-usual guidance was delivered without consideration of patient CYP2D6 genotype, and 982 to genetically-guided therapy (Group G) where CYP2D6-based treatment recommendations were provided via EMR to physicians. For inpatients in Group G whose CYP2D6 function was sub- or supra-normal, medications primarily metabolized by the CYP2D6 enzyme were proscribed.

The RCT developed a database of potential benefit to the field. The pharmacologic, clinical course and pharmacogenetic therapeutic guidance is being published in a related article. These data should enable various investigators to assess effects of clinical decision support on resource utilization and psychotropic therapy during psychiatric hospitalizations.

CYP-GUIDES（细胞色素精神药物基因分型决策支持研究，Cytochrome Psychotropic Genotyping Under Investigation for Decision Support）是一项随机对照试验（randomized controlled trial，以下简称RCT），旨在对比接受基于患者CYP2D6基因型与功能状态制定的治疗方案，与标准精神药物治疗的住院重度抑郁障碍患者的两类结局。该试验的主要结局为住院时长（Length of Stay，以下简称LOS），次要结局为出院后30天内的再入院率（Re-Admission Rate，以下简称RAR）。
试验开展于哈特福德医院生活研究所（Institute of Living at Hartford Hospital）。研究通过CYP2D6基因分型对受试者的CYP2D6酶功能状态进行表征，将其分为功能低下、正常及功能亢进三类。本研究借助电子病历（electronic medical record，以下简称EMR），将基于患者CYP2D6功能的临床可执行药物处方指导推送至主治医师端。
本RCT共招募1500名受试者，其中1459例完成CYP2D6基因分型，并将其随机分为两组：标准治疗组（S组）477例，该组采用常规治疗方案，无需考量患者CYP2D6基因型；基因指导治疗组（G组）982例，该组通过EMR向医师推送基于CYP2D6的治疗建议。对于G组中CYP2D6功能低下或亢进的住院患者，临床优先禁用主要经CYP2D6酶代谢的药物。
本随机对照试验构建了一项对本领域具有潜在应用价值的数据库。相关研究文章将发表其药物学特征、临床病程及药物遗传学治疗指导方案。该数据集可供各类研究者评估临床决策支持对精神科住院患者资源利用及精神药物治疗的影响。