Actively Recruiting
TACS on High-inflammatory and Refractory Depression
Led by Tianjin Anding Hospital · Updated on 2025-02-06
52
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized controlled trial with a duration of 12 weeks (4 weeks of intervention + 8 weeks of follow-up). The participants are patients with treatment-resistant depression (TRD) and high inflammatory activity (n=52). The study aims to clarify the effectiveness of 15mA, 77.5Hz transcranial alternating current stimulation (tACS) in treating TRD with high inflammatory activity by comparing the changes in depressive symptoms and biological markers after active tACS stimulation versus sham stimulation. Additionally, the study seeks to explore potential underlying mechanisms of action.
CONDITIONS
Official Title
TACS on High-inflammatory and Refractory Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 55 years
- Diagnosed with depression by a psychiatrist using DSM-5
- HAMD-17 total score of 17 or above, with a score of 2 or more on item 1 (depression)
- C-reactive protein (CRP) level between 0.85 and 10 mg/L
- DM-TRD score of at least 12.5
- Stable use of antidepressant or antipsychotic medications for at least 2 weeks during current depressive episode
- Able to understand and sign the informed consent form
You will not qualify if you...
- History of seizures, epilepsy, hydrocephalus, central nervous system tumors, acute brain injury, or infections
- Score of 3 or 4 on item 3 of HAMD-17 or history of suicidal behavior with significant risk
- Received electroconvulsive therapy, modified electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, tACS, or other neuromodulation treatments within 1 month prior to enrollment
- Pregnant or breastfeeding women
- Severe organic disease or unstable condition due to organic disease
- Used anti-inflammatory drugs for more than 7 days cumulatively in last 2 months or used immunosuppressive drugs such as corticosteroids
- Chronic infectious or autoimmune diseases (e.g., lupus, enteritis, hepatitis)
- History of substance dependence or substance abuse
AI-Screening
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Trial Site Locations
Total: 1 location
1
The 20th ward of general psychiatric department
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
C
Chenghao Yang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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