Acupuncture and Escitalopram for Treating Major Depression Clinical Study

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

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

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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Other: acupuncture
* Other: escitalopram
* Other: sham-acupuncure
* Other: escitalopram placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham-acupuncture/placebo-pill<br>sham-acupuncture protocol plus escitalopram placebo | Other: sham-acupuncure<br>* In the sham acupuncture group, superficial skin penetration (2 to 3 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.<br>Other: escitalopram placebo<br>* Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.<br>|
| Active Comparator: sham-acupuncture/escitalopram<br>sham-acupuncture protocol plus escitalopram | Other: escitalopram<br>* Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.<br>Other: sham-acupuncure<br>* In the sham acupuncture group, superficial skin penetration (2 to 3 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.<br>|
| Active Comparator: active acupuncture/placebo-pill<br>acupuncture protocol plus escitalopram placebo | Other: acupuncture<br>* The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include 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.<br>* Other names: active acupuncture;Other: escitalopram placebo<br>* Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.<br>|
| Experimental: active acupuncture/escitalopram<br>acupuncture protocol plus escitalopram | Other: acupuncture<br>* The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include 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.<br>* Other names: active acupuncture;Other: escitalopram<br>* Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDRS-17 score | the change in the HDRS-17 score | from baseline to 10 weeks | 

Secondary Outcome Measures

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