Introduction: As a major public health problem, depression has a negative impact on individuals and society. The aim of this well-designed trial is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for depression.
Methods/design: A 3-arm parallel, nonblinded, randomized controlled trial will be performed in 4 hospitals (centers). A total of 144 participants will be divided into 3 groups: EA group, manual acupuncture (MA) group, and western medicine group. Participants in EA group and MA group will receive 12 sessions of acupuncture treatment for 4 weeks. Participants allocated to western medicine group will only take 20 mg fluoxetine orally per day for 4 weeks. The primary outcome is Hamilton Depression Scale. Secondary outcomes are Self-Rating Depression Scale, Depression Scale of traditional Chinese medicine (Depression Scale of Traditional Chinese Medicine), brain fMRI and blood biomarkers including neurotransmitters serotonin, dopamine, noradrenaline, inflammatory cytokines inerleukin (IL)-1β, tumor necrosis factor-α, IL-6, and neurotrophin BDNF. All the outcomes will be assessed at baseline, 4 weeks after EA treatment onset and 6-month follow-up.
Discussion: The results of this trial will verify the efficacy and safety of EA treatment for depressive patients and provide acupuncturists and clinicians with robust clinical evidence.
Trial registration: Chinese Clinical Trial Registry identifier: ChiCTR1900023420. Version 1. Registered on 26 May 2019. http://www.chictr.org.cn/edit.aspx?pid=37621&htm=4.