A clinical research based on multi-fMRI of acupuncture combined with SSRIs treating major depressive disorder

Phase 1

Recruiting

• Conditions: Major Depression Disorder

• Registration Number: ITMCTR2200005740
• Lead Sponsor: Shuguang Hospital Attached with Shanghai Chinese Medicine University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1) Patients who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), published by The American Psychological Association (APA) in 2013.
2) Between the ages of 18 and 65 years, regardless of gender
3) Score of >20 on the 24-item Hamilton Depression Inventory (HAMD24) and score of =2 on HAMD24 item 1 (depressed mood)
4) Clinical General Impression Inventory-Severity of Illness (CGI-S) score = 4
5) Right-handedness.
6) The patient understands and voluntarily accepts the treatment and signs an informed consent form.

Exclusion Criteria

1) Persons with a history of suicide attempts, serious suicidal ideation or high risk of self-injury within 1 year prior to the enrolment period
2) Those with a history of alcohol or other drug dependence or abuse within 1 year prior to the enrollment period
3) Those who have participated in a clinical trial of another drug within 3 months prior to the enrollment period
4) Those who have received electroconvulsive therapy, transcranial magnetic stimulation or other physiotherapy within 3 months prior to the enrolment period
5) Persons with other psychotic disorders such as bipolar disorder
6) Those with organic brain disease.
7) Those with other systemic disorders such as severe cardiovascular, endocrine or immune deficiencies
8) Women who are pregnant, preparing for pregnancy or breastfeeding
9) Those who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HAMD24;

Secondary Outcome Measures

Name	Time	Method
VAS;HAMA;PSQI;SERS;