Acupuncture and Escitalopram for Treating Major Depression Clinical Study

Not Applicable

Not yet recruiting

• Conditions: Depressive Disorder, Major
• Interventions: Other: acupuncture; Other: sham-acupuncure; Other: escitalopram; Other: escitalopram placebo

• Registration Number: NCT05901571
• Lead Sponsor: Shanghai 7th People's Hospital

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 Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Last Update Submitted: 2023-06-05
• Study First Posted: 2023-06-13
• Last Update Posted: 2023-06-13
• Study Start: 2023-09
• Primary Completion: 2026-09
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active acupuncture/placebo-pill	acupuncture	acupuncture protocol plus escitalopram placebo
sham-acupuncture/placebo-pill	sham-acupuncure	sham-acupuncture protocol plus escitalopram placebo
sham-acupuncture/placebo-pill	escitalopram placebo	sham-acupuncture protocol plus escitalopram placebo
sham-acupuncture/escitalopram	escitalopram	sham-acupuncture protocol plus escitalopram
sham-acupuncture/escitalopram	sham-acupuncure	sham-acupuncture protocol plus escitalopram
active acupuncture/escitalopram	escitalopram	acupuncture protocol plus escitalopram
active acupuncture/placebo-pill	escitalopram placebo	acupuncture protocol plus escitalopram placebo
active acupuncture/escitalopram	acupuncture	acupuncture protocol plus escitalopram

Primary Outcome Measures

Name	Time	Method
HDRS-17 score	from baseline to 10 weeks	the change in the HDRS-17 score

Secondary Outcome Measures

Name	Time	Method
The CGI(Clinical Global Impression)	from baseline to 10 weeks	the change in the CGI
Beck depression inventory score	from baseline to 10 weeks	the change in the Beck depression inventory score
The GAD-7(General Anxiety Disorder)	from baseline to 10 weeks	the change in the GAD-7
The Mini-Mental State Examination (MMSE)	from baseline to 10 weeks	the change in the MMSE

Trial Locations

Locations (3)

Zhenxiang Han; 🇨🇳 Shanghai, Shanghai, China

Jianhua Chen; 🇨🇳 Shanghai, Shanghai, China

Zouqing Huang; 🇨🇳 Shanghai, Shanghai, China