Not yet recruiting NCT05901571

Acupuncture and Escitalopram for Treating Major Depression Clinical Study

No phase Interventional Depressive Disorder, Major

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: acupuncture, escitalopram, sham-acupuncure, escitalopram placebo.
Who it may be relevant to: Registry conditions: Depressive Disorder, Major. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial

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.

Other acupuncture
The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include DU20（Baihui) and SP4 (Gongsun) , PC6 (Neiguan) , PC5 (Jianshi) and LV 3 (Taichong) bilaterally. All acupoints are localized according to the WHO Standard Acupuncture Locations.After needle insertion, the acupuncture needles will be manipulated using either the twirling-rotating or lifting-thrusting methods to achieve the "De Qi" sensation.
Other escitalopram
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
Other sham-acupuncure
In the sham acupuncture group, superficial skin penetration (2 mm in depth) at nonacupoints will be done without De Qi manipulations. Nonacupoints are away from conventional acupoints or meridians. The choice of sham acupuncture points, which are points located in an emplacement different than the meridian points. The sham acupoints are not standard acupoints and will be about 1cun ( ≈20 mm) lateral from the real acupoints in the experimental group.
Other escitalopram placebo
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.

Secondary outcome measures (4)

Beck depression inventory scale [Time frame: from baseline to 10 weeks]
The CGI(Clinical Global Impression) scale [Time frame: from baseline to 10 weeks]
The GAD-7(General Anxiety Disorder) scale [Time frame: from baseline to 10 weeks]
The Mini-Mental State Examination (MMSE) scale [Time frame: from baseline to 10 weeks]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 3 centers

Yang K, Tiwari S, Liu D, Xu Q, Qi L, Zhu Y, Jiang L, Zouqin H, Wong J, Chen J, Han Z. Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): protocol for a factorial randomised controlled trial. BMJ Open. 2024 Sep 10;14(9):e091214. doi: 10.1136/bmjopen-2024-091214. PMID 39260834

NCT: NCT05901571 · PWRl2021-05 · 21Y11921000 · 21ZR1449300