Summary of data collection schedule for phase 2.

Obesity is a global public health concern, often co-occurring in patients with severe mental illnesses. The impact of psychotropic drugs-induced weight gain is augmenting the disease burden and healthcare expenditure. However, predictors of psychotropic drug-induced weight gain and the efficacy of anti-obesity drugs remain underexplored. This study aims to develop a machine learning algorithm to predict both psychotropic drugs-induced weight gain and metabolic changes, and the potential of anti-obesity drugs. We plan to enroll 300 patients with severe mental illnesses, including schizophrenia, bipolar disorder, and major depressive disorder. In Phase 1, the study will predict weight gain and metabolic changes after the psychotropic treatment. Data on demographics, lifestyle, medical history, psychological factors, anthropometrics, and laboratory results will be collected at baseline and re-evaluated 24 weeks post-treatment. Participants classified as obese (body mass index ≥ 25 kg/m²) or overweight (body mass index of 23–24.9 kg/m²) at the 24-week follow-up will proceed to Phase 2, which focuses on predicting the promise of anti-obesity drugs. The study participants will receive anti-obesity medications for 24 weeks, and the same variables from Phase 1 will be reassessed. A machine learning model will be developed to predict both psychotropic drug-induced weight gain and anti-obesity medications that will be effective. The algorithm will be tailored to each patient to guide clinicians in personalizing psychiatric and obesity treatment plans. The clinical trial is registered with the Clinical Research Information Service, part of the WHO International Clinical Trials Registry Platform (approval number: KCT0009769).肥胖是一项全球性公共卫生议题，且常与重型精神疾病患者共病。精神药物（psychotropic drugs）诱导的体重增加所带来的影响，正不断加重疾病负担与医疗开支。然而，目前针对精神药物诱导体重增加的预测因子，以及抗肥胖药物的疗效，相关研究仍有待深入探索。本研究旨在开发一款机器学习算法，以同时预测精神药物诱导的体重增加与代谢变化，以及抗肥胖药物的应用潜力。本研究计划招募300名重型精神疾病患者，涵盖精神分裂症、双相情感障碍及重度抑郁症患者。在第一阶段，本研究将预测精神药物治疗后的体重增加与代谢变化情况。研究将在基线阶段收集受试者的人口学特征、生活方式、病史、心理因素、人体测量学指标及实验室检测结果，并在治疗后24周进行二次评估。在24周随访时被判定为肥胖（身体质量指数（body mass index）≥25 kg/m²）或超重（身体质量指数为23~24.9 kg/m²）的受试者，将进入第二阶段研究，该阶段聚焦于预测抗肥胖药物的应用前景。受试者将接受为期24周的抗肥胖药物治疗，并对第一阶段采集的同类指标进行重新评估。本研究将开发一款机器学习模型，以同时预测精神药物诱导的体重增加情况与有效的抗肥胖药物方案。该算法将针对每位患者进行个性化定制，以辅助临床医生制定个体化的精神疾病与肥胖治疗方案。本临床试验已注册于隶属于世界卫生组织（WHO）国际临床试验注册平台的临床研究信息服务中心，批准编号为KCT0009769。