Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS)

Shanghai 7th People's Hospital

Status: Not yet enrolling

Conditions: Depressive Disorder, Major

Treatments: Other: escitalopram; Other: escitalopram placebo; Other: sham-acupuncure; Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05901571

21ZR1449300 (Other Grant/Funding Number)

PWRl2021-05

21Y11921000 (Other Grant/Funding Number)

Details and patient eligibility

About

We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.

Full description

This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between 18 and 75 years of age with no gender-based restriction.
2. Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.
3. A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17
4. Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.
5. The absence of acupuncture treatment within at least 1 year.
6. Willingness to participate in the trial and provide written informed consent for the clinical trial.

Exclusion criteria

1. Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.
2. 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.
3. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.
4. Pregnancy or breastfeeding.
5. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.
6. Candidates afraid of needles in general and reluctant to receive acupuncture in particular
7. Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).
8. Previous participation in other acupuncture trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 4 patient groups

sham-acupuncture/placebo-pill

Sham Comparator group

Description:

sham-acupuncture protocol plus escitalopram placebo

Treatment:

Other: escitalopram placebo

Other: sham-acupuncure

sham-acupuncture/escitalopram

Active Comparator group

Description:

sham-acupuncture protocol plus escitalopram

Treatment:

Other: sham-acupuncure

Other: escitalopram

active acupuncture/placebo-pill

Active Comparator group

Description:

acupuncture protocol plus escitalopram placebo

Treatment:

Other: acupuncture

Other: escitalopram placebo

active acupuncture/escitalopram

Experimental group

Description:

acupuncture protocol plus escitalopram

Treatment:

Other: acupuncture

Other: escitalopram