Effectiveness of Electro-Acupuncture on treating MDD: a Randomized Controlled Trial
- Conditions
- Major Depressive Disorder
- Registration Number
- ITMCTR2000003083
- Lead Sponsor
- Shanghai Seventh People's Hospital, Shanghai University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Patients with MDD who meet the following criteria will be included:
1. Between 18 and 75 years of age with no gender-based restriction;
2. Fulfilling the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM V) for major depressive disorder;
3. A Hamilton Rating Scale for Depression (HDRS-17) score with a range between 17 to 24 (24 > HDRS-17 >= 17);
4. Non-aphasic and without severe cognitive disorders, with a Mini-Mental State Examination (MMSE) score (H) greater than 17 (MMSE > 17);
5. Keenness to participate in the trial and provide written informed consent.
Subjects reporting any of the following criteria will be excluded:
1. History or current presence of neuropsychiatric diseases other than depression
2. Candidates at a high risk of attempting suicide (a score of more than 2 points on the third question (Suicide) of the HDRS-17
3. People who, prior to the date of screening:
Have taken antidepressants or any psychotropic drugs;
Have undergone psychotherapy or Cognitive Behavioral Therapy (CBT);
Received any kind of therapeutic interventions related to either Western medical practice or
Traditional Chinese Medicine to alleviate the symptoms of MDD.
4. Pregnant, lactating, or planning to become pregnant women;
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. Patients with bleeding tendency, severe physical disability or other chronic disorders (e.g: chronic alcoholism, drug abuse);
8. Subject who have already taken part in previous clinical trials where EA treatment was used.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 17-item Hamilton Depression Scale (HDRS-17);
- Secondary Outcome Measures
Name Time Method Mini-Mental State Examination (MMSE);Zung Self-Rating Depression Scale (SDS);IL-1ß/IL-18;