Comparison of effects and brain imaging mechanisms of acupuncture and paroxetine for depressive patients with suicidal ideation: study protocol of a 20-week clinical trial

Abstract

Background Suicide is a devastating and major medical and social problem, and effective management of depression with suicidal ideation (DWSI) is of significant importance in reducing suicide rates. Acupuncture has been less studied in DWSI, and its central mechanisms have not been elucidated. This study aims to carry out a clinical trial using multimodal brain imaging techniques to investigate the mechanism of brain network regulation of DWSI by acupuncture. Method A total of 70 patients with DWSI and 30 healthy subjects will be recruited for this study. This trial will include a 1-week baseline phase, a 12-week treatment phase, and a 8-week follow-up phase. Patients in the acupuncture group will receive 36 sessions of acupuncture, 3 times a week for 12 weeks. Patientsin the paroxetine control group will receive paroxetine 10 mg per day (week 1), 20 mg per day (weeks 2); and 30 mg per day (weeks 3-12). The primary outcomes are the mean change in the Hamilton Depression Rating Scale-24 scores and the Beck scale for suicide ideation. The secondary outcomes include the Depression Self-Rating Scale, Clinical Global ImpressionsScale, Asberg Antidepressant side effect scale and World Health Organization Quality of Life Questionaire abbreviated version. Magnetic resonance imaging data will be collected from each participant at baseline and each patient at the end of treatment. Conclusions This study hypothesised that acupuncture therapy could treat DWSI by restoring the pathological center of suicidal ideation in brain. This study will clarify the mechanism of brain network regulation of DWSI by acupuncture. Trial registration number ChiCTR2200059267, registered on April 7, 2022.