NCT05901571尚未招募不适用
Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial
Shanghai 7th People's Hospital3 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2026年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- HDRS-17 scale
研究概览
简要总结
We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.
详细描述
This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years of age with no gender-based restriction.
- •Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.
- •A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17
- •Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.
- •The absence of acupuncture treatment within at least 1 year.
- •Willingness to participate in the trial and provide written informed consent for the clinical trial.
排除标准
- •Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.
- •High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry.
- •Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.
- •Pregnancy or breastfeeding.
- •Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.
- •Candidates afraid of needles in general and reluctant to receive acupuncture in particular
- •Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).
- •Previous participation in other acupuncture trials.
研究组 & 干预措施
sham-acupuncture/escitalopram
Active Comparator
sham-acupuncture protocol plus escitalopram
干预措施: sham-acupuncure (Other)
sham-acupuncture/escitalopram
Active Comparator
sham-acupuncture protocol plus escitalopram
干预措施: escitalopram (Other)
sham-acupuncture/placebo-pill
Sham Comparator
sham-acupuncture protocol plus escitalopram placebo
干预措施: escitalopram placebo (Other)
sham-acupuncture/placebo-pill
Sham Comparator
sham-acupuncture protocol plus escitalopram placebo
干预措施: sham-acupuncure (Other)
active acupuncture/placebo-pill
Active Comparator
acupuncture protocol plus escitalopram placebo
干预措施: acupuncture (Other)
active acupuncture/escitalopram
Experimental
acupuncture protocol plus escitalopram
干预措施: acupuncture (Other)
active acupuncture/placebo-pill
Active Comparator
acupuncture protocol plus escitalopram placebo
干预措施: escitalopram placebo (Other)
active acupuncture/escitalopram
Experimental
acupuncture protocol plus escitalopram
干预措施: escitalopram (Other)
结局指标
主要结局
HDRS-17 scale
时间窗: from baseline to 10 weeks
the change in the HDRS-17 score
次要结局
- Beck depression inventory scale(from baseline to 10 weeks)
- The CGI(Clinical Global Impression) scale(from baseline to 10 weeks)
- The GAD-7(General Anxiety Disorder) scale(from baseline to 10 weeks)
- The Mini-Mental State Examination (MMSE) scale(from baseline to 10 weeks)
研究者
研究点 (3)
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