Clinical trial NCT05901571: Acupuncture and Escitalopram for Treating Major Depression Clinical Study
Official title: Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder, Major
Lead sponsor: Shanghai 7th People's Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HDRS-17 score
timeFrame: from baseline to 10 weeks
Secondary outcomes:
measure: Beck depression inventory score
timeFrame: from baseline to 10 weeks
measure: The CGI(Clinical Global Impression)
timeFrame: from baseline to 10 weeks
measure: The GAD-7(General Anxiety Disorder)
timeFrame: from baseline to 10 weeks
measure: The Mini-Mental State Examination (MMSE)
timeFrame: from baseline to 10 weeks
Other outcomes:
measure: BDNF
timeFrame: at baseline and 10 week
measure: IL18/IL-1β
timeFrame: at baseline and 10 week
measure: fMRI
timeFrame: at baseline and 10 week
Locations:
city: Shanghai
country: China
facility: Jianhua Chen
state: Shanghai
city: Shanghai
country: China
facility: Zhenxiang Han
state: Shanghai
city: Shanghai
country: China
facility: Zouqing Huang
state: Shanghai
Study officials:
affiliation: Shanghai Seventh People's Hospital, Shanghai University of TCM
name: Zhenxiang Han, Dr
role: PRINCIPAL_INVESTIGATOR
References: