NCT05901571Not yet recruitingNot Applicable
Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial
Shanghai 7th People's Hospital3 sites in 1 country216 target enrollmentStarted: November 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 216
- Locations
- 3
- Primary Endpoint
- HDRS-17 scale
Study Overview
Brief Summary
We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.
Detailed Description
This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
sham-acupuncture/escitalopram
Active Comparator
sham-acupuncture protocol plus escitalopram
Intervention: sham-acupuncure (Other)
sham-acupuncture/escitalopram
Active Comparator
sham-acupuncture protocol plus escitalopram
Intervention: escitalopram (Other)
sham-acupuncture/placebo-pill
Sham Comparator
sham-acupuncture protocol plus escitalopram placebo
Intervention: escitalopram placebo (Other)
sham-acupuncture/placebo-pill
Sham Comparator
sham-acupuncture protocol plus escitalopram placebo
Intervention: sham-acupuncure (Other)
active acupuncture/placebo-pill
Active Comparator
acupuncture protocol plus escitalopram placebo
Intervention: acupuncture (Other)
active acupuncture/escitalopram
Experimental
acupuncture protocol plus escitalopram
Intervention: acupuncture (Other)
active acupuncture/placebo-pill
Active Comparator
acupuncture protocol plus escitalopram placebo
Intervention: escitalopram placebo (Other)
active acupuncture/escitalopram
Experimental
acupuncture protocol plus escitalopram
Intervention: escitalopram (Other)
Outcomes
Primary Outcomes
HDRS-17 scale
Time Frame: from baseline to 10 weeks
the change in the HDRS-17 score
Secondary Outcomes
- 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)
Investigators
Study Sites (3)
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