Efficacy and Safety of Remote Ischemic Conditioning for Depression Insufficiently Responsive to Antidepressant: A Randomized Controlled Trial

Jun Wang,1,* Yu Shuai,1,* Ming Ren,2,* Ningning Li,3 Xujuan Li,4 Wenfei Li,5 Binxun Jiang,4 Linlin Wang,4 Leping Huang,3 Xunming Ji,6,7 Zuowei Wang3,8 1Division of Mood Disorders, Shanghai Yangpu Mental Health Center, Shanghai, 200093, People’s Republic of China; 2Department of Neurology, Shanghai Blue Cross Brain Hospital, Tongji University, Shanghai, 200086, People’s Republic of China; 3Division of Mood Disorders, Shanghai Hongkou Mental Health Center, Shanghai, 200083, People’s Republic of China; 4Division of Mood Disorders, Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan International Medical College, Hangzhou, 310022, People’s Republic of China; 5Division of Mood Disorders, Anhui Mental Health Center, Hefei. Anhui, 230022, People’s Republic of China; 6Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, 100053, People’s Republic of China; 7Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, 100053, People’s Republic of China; 8Clinical Research Center for Mental Health, School of Medicine, Shanghai University, Shanghai, 200083, People’s Republic of China*These authors contributed equally to this workCorrespondence: Zuowei Wang, Division of Mood Disorders, Shanghai Hongkou Mental Health Center, Shanghai, 200083, People’s Republic of China, Email [email protected] Xunming Ji, Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, 100053, People’s Republic of China, Email [email protected]: Physical therapies are recommended for individuals who are insufficiently responsive to pharmacotherapy and psychotherapy. But most physical therapy needs to be done in a hospital, so finding a physical therapy that can be done at home is very meaningful. This study intends to explore the efficacy and safety of remote ischemic preconditioning (RIPC) as an add-on therapy for depression.Methods: A total of 60 major depressive disorder patients with inadequate response to escitalopram in this study were randomly assigned to sham or active RIPC group. The clinical symptoms, side-effects and physical examination were evaluated and recorded once every 2 weeks until the end of 8th week. The clinical symptoms were evaluated using the 16-item Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-16-SR) and the Generalized Anxiety Disorder 7-item scale (GAD-7). Side-effects included skin ecchymosis, risk of manic episodes, and RIPC-related serious adverse events. Physical examination included heart rate and blood pressure.Results: No significant difference in QIDS-16-SR and GAD-7 scores between the two groups was found at baseline, week 2, week 4, week 6 and week 8 (P > 0.05). There were no significant differences in heart rate and blood pressure (including systolic and diastolic blood pressure) at any time point between the active group and the sham group (P > 0.05). There were no manic or hypomanic episodes associated with the study.Conclusion: For depression patients with poor response to antidepressant therapy, the efficacy of RIPC as adjuvant therapy was not observed in this study. In general, RIPC adjuvant therapy is relatively safe, and has no significant effect on cardiovascular system, nor does it increase the risk of manic episode.Keywords: depression patient, efficacy, physical therapy, remote ischemic, safety