RecruitingNot ApplicableNCT06812923

TACS on High-inflammatory and Refractory Depression

The Study on Effectiveness and Mechanisms of Transcranial Alternating Current Stimulation in Treating Increased Inflammatory Activity Refractory Depression


Sponsor

Tianjin Anding Hospital

Enrollment

52 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing transcranial alternating current stimulation (TACS) — a non-invasive brain stimulation technique that uses mild electrical currents on the scalp — as a treatment for people with depression that involves high levels of inflammation and has not responded to standard antidepressant medications. **You may be eligible if...** - You are between 18 and 55 years old - You have been diagnosed with depression by a psychiatrist using standard criteria (DSM-5) - Your depression score is 17 or higher on the Hamilton Depression Rating Scale - Your CRP level (a blood marker of inflammation) is between 0.85 and 10 mg/L - Your depression has not responded to at least some treatment (treatment-resistant) - You have been on a stable dose of antidepressants or antipsychotics for at least 2 weeks **You may NOT be eligible if...** - You have a history of epilepsy, seizures, brain tumors, or acute brain injury - You have metal implants in your head or a pacemaker - You are pregnant or breastfeeding - You have other major psychiatric diagnoses that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtranscranial Alternating Current Stimulation (tACS)

tACS, parameters: 15mA、77.5Hz tACS, 20 times (5 times a week, four weeks totally)

DEVICESham stimulation

Sham stimulation, matched with real tACS, except for providing electrical stimulation


Locations(1)

The 20th ward of general psychiatric department

Tianjin, Tianjin Municipality, China

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NCT06812923


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