RT Journal Article
SR Electronic
T1 Effects of intermittent theta burst stimulation (iTBS) on appetite change and body weight in inpatients with schizophrenia in China: study protocol for a randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e090932
DO 10.1136/bmjopen-2024-090932
VO 15
IS 4
A1 Qin, Yue
A1 Yang, Jin
A1 Xu, Baoyan
A1 Yang, Jun
A1 Chen, Haiyu
A1 Zou, Tianxiang
A1 Teng, Ziwei
A1 Liu, Jieyu
A1 Zhang, Tengteng
A1 Su, Yuhan
A1 Wu, Renrong
A1 Dong, Zaiwen
A1 Yang, Chong
A1 Huang, Jing
YR 2025
UL http://bmjopen.bmj.com/content/15/4/e090932.abstract
AB Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05783063.