Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS)
Depressive Disorder, Major
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
Eligibility Criteria
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.
Sites / Locations
- Jianhua Chen
- Zhenxiang Han
- Zouqing Huang
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Sham Comparator
Active Comparator
Active Comparator
Experimental
sham-acupuncture/placebo-pill
sham-acupuncture/escitalopram
active acupuncture/placebo-pill
active acupuncture/escitalopram
sham-acupuncture protocol plus escitalopram placebo
sham-acupuncture protocol plus escitalopram
acupuncture protocol plus escitalopram placebo
acupuncture protocol plus escitalopram