Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 23, 2025
Date Accepted: Dec 8, 2025
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Efficacy of acupuncture for mild to moderate depression in elderly people: a protocol of randomized controlled trial
ABSTRACT
Background:
Selective serotonin reuptake inhibitors (SSRIs) are first-line antidepressants, however, only around 60% of patients could benefit from them. Acupuncture is supported by insufficient evidence to help with symptom relieving and SSRIs tolerance.
Objective:
This randomized controlled trial aims to assess the effects of acupuncture combined with citalopram hydrobromide on mild to moderate depression in elderly people.
Methods:
This study design is a two-arm, parallel, randomized controlled trial. 132 participants aged from 60 to 80 years old, diagnosed with major depressive disorder, will be divided into acupuncture and medication group or medication group. Participants of both groups take citalopram hydrobromide up to 20mg daily for 12 weeks. The acupuncture and medication group additionally receives 36 sessions acupuncture treatment over 12 weeks. The primary outcome is response rate of the 17-item Hamilton Depression Scale (HAMD-17) at 8th week. The secondary outcomes include the changes in HAMD-17scores and MMSE scores at various time. Adverse events will be recorded in detail.
Results:
The study commenced on June 30, 2023, and as of October 17, 2024, a total of 132 participants have been enrolled. Data collection has been completed. Currently, data analysis is in progress, with preliminary findings anticipated to be available by October 2025. The findings of this study are expected to be submitted for publication in 2026.
Conclusions:
This pilot study is expected to provide critical insights into the feasibility of integrating acupuncture with standard medication for managing mild to moderate depression in elderly people. By generating preliminary evidence on its potential benefits, the study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for depression. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2300072740; https://www.chictr.org.cn/bin/project/edit?pid=198821
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