Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
NCT06812923

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

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The 20th ward of general psychiatric department

Tianjin, Tianjin Municipality, China, 300000

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here