Qin Yue, Yang Jin, Xu Baoyan, Yang Jun, Chen Haiyu, Zou Tianxiang, Teng Ziwei, Liu Jieyu, Zhang Tengteng, Su Yuhan, Wu Renrong, Dong Zaiwen, Yang Chong, Huang Jing
The Second People's Hospital of Dali Bai Autonomous Prefecture, Dali, Yunnan, China.
Department of Psychiatry, National Clinical Research Center for Mental Disorders, National Center for Mental Disorders, and China National Technology Institute on Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
BMJ Open. 2025 Apr 8;15(4):e090932. doi: 10.1136/bmjopen-2024-090932.
Antipsychotics are likely to cause weight gain owing to increased appetite and other metabolic disturbances in patients with schizophrenia on prolonged medication. Conventional high-frequency repetitive transcranial magnetic stimulation has been employed to treat people with obesity and has shown certain effectiveness. The goal of this clinical trial is to evaluate the efficacy of intermittent theta burst stimulation (iTBS) in ameliorating appetite increase and weight gain induced by antipsychotics in patients with schizophrenia.
In this randomised, double-blind, sham-controlled trial, 60 participants will be enrolled and allocated (1:1) to receive active or sham iTBS on the dorsolateral prefrontal cortex for 5 consecutive days. Appetite, body mass index, clinical symptoms, cognitive function and laboratory indicators will be assessed at baseline, after 5 days of treatments, and at 2 weeks and 4 weeks after all treatments. MRI examination will be conducted to detect brain structure, perfusion and functional connectivity. Data analysis will be conducted in a modified intention-to-treat population. The results of the study will provide evidence on the effectiveness and feasibility of iTBS in improving increased appetite induced by antipsychotics and explore the underlying neuroendocrine pathway affected by the intervention. The primary objective is to evaluate the efficacy of iTBS in weight gain in patients with schizophrenia taking antipsychotics. The secondary objective is to identify the neuroendocrine changes related to appetite in response to iTBS by assessing the variables of cognitive control, glucolipid metabolism and brain activity.
The study protocol has been approved by the National Clinical Medical Research Center Ethics Committee of The Second People's Hospital of Dali Bai Autonomous Prefecture (no: 2023YN3) and The Second Xiangya Hospital (no: 2024K008). Written informed consent will be obtained voluntarily before enrolment. The results will be disseminated through publication in peer-reviewed journals and presentation at international conferences.
NCT05783063.
抗精神病药物可能会导致体重增加，这是由于精神分裂症患者长期服药后食欲增加及其他代谢紊乱所致。传统的高频重复经颅磁刺激已被用于治疗肥胖症患者，并显示出一定的疗效。本临床试验的目的是评估间歇性theta爆发刺激（iTBS）改善抗精神病药物引起的精神分裂症患者食欲增加和体重增加的疗效。
在这项随机、双盲、假刺激对照试验中，将招募60名参与者并（1:1）分配，连续5天接受背外侧前额叶皮质的活性或假iTBS治疗。在基线、治疗5天后、所有治疗结束后2周和4周时评估食欲、体重指数、临床症状、认知功能和实验室指标。将进行MRI检查以检测脑结构、灌注和功能连接。数据分析将在改良的意向性治疗人群中进行。该研究结果将为iTBS改善抗精神病药物引起的食欲增加的有效性和可行性提供证据，并探索受干预影响的潜在神经内分泌途径。主要目的是评估iTBS对服用抗精神病药物的精神分裂症患者体重增加的疗效。次要目的是通过评估认知控制、糖脂代谢和脑活动变量来确定与iTBS反应中食欲相关的神经内分泌变化。
该研究方案已获得大理白族自治州第二人民医院国家临床医学研究中心伦理委员会（编号：2023YN3）和中南大学湘雅二医院（编号：2024K008）的批准。入组前将自愿获得书面知情同意书。研究结果将通过在同行评审期刊上发表及在国际会议上展示进行传播。
NCT05783063。
