Match the diagnostic criteria of DSM-5 for MDD
Conditions
Interventions
placebo group:sham-acupuncture/placebo-pill
acupuncture group:active acupuncture/placebo-pill
active acupuncture/escitalopram:active acupuncture/escitalopram
escitalopram group:sham-acupuncture/escitalopram
Sponsors
Seventh People's Hospital of Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Ages between 18 and 75, with no gender-based restriction 2: Match the diagnostic criteria of DSM-5 for MDD 3: Have a Hamilton Rating Scale for Depression (HDRS-17) score > 17 4: Be able to read and understand Mandarin Chinese, have at least nine years of education 5: Receive no acupuncture treatment within the past years 6: Will to participate in the trial and provide written informed consent for the clinical trial
Exclusion criteria
Exclusion criteria: 1: Have lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth 2: Have high suicide risk or suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry 3: Be medicated with antidepressant at the start of the trial or a history of treatment failure with escitalopram 4: Be pregnant or is breastfeeding 5: Have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture 6: Be afraid of needles in general and reluctant to receive acupuncture in particular 7: Be suspected of clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency) 8: Have previous participation in other acupuncture trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale;BDNF;IL-1ß/IL-18; | — |
Secondary
| Measure | Time frame |
|---|---|
| General Anxiety Disorder;the Mini-mental State Examination;Clinical Global Impression; | — |
Countries
China
Contacts
Public ContactZhenxiang Han
Seventh People's Hospital of Shanghai University of TCM
Outcome results
None listed