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NCT06812923Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
52 (estimated)
First submitted
2 Feb 2025
Start date
1 Jan 2025
Primary completion date
31 Dec 2027
Lead sponsor
Tianjin Anding Hospital
Diseases
Depression
NCT number
NCT06812923

What you commit to

  • Study type: Interventional
  • Planned participants: 52
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • (1) A history of current or past seizures, epilepsy, hydrocephalus, central nervous system tumors, or acute brain injury and infections; (2) A score of 3 or 4 on item 3 of the HAMD-17, or a history of suicidal behavior with significant suicide risk; (3) Received electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neuromodulation treatments within one month prior to enrollment; (4) Pregnant or breastfeeding women; (5) Patients with any severe organic disease or in an unstable condition due to organic disease; (6) Used anti-inflammatory drugs for more than 7 days cumulatively in the last 2 months, or used immunosuppressive drugs, such as corticosteroids; (7) Suffering from chronic infectious or autoimmune diseases, such as lupus, enteritis, hepatitis, etc.; (8) A history of substance dependence or substance abuse.

Who the study is looking for

  • (1) Aged between 18 and 55 years; (2) Diagnosed with depression through a structured clinical interview by a psychiatrist using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) A total score of 17 or above on the 17-item Hamilton Depression Rating Scale (HAMD-17), with a score of 2 or more on item 1 (depression); (4) CRP level between 0.85-10 mg/L; (5) DM-TRD score of at least 12.5; (6) Stable use of treatment medications (antidepressants, antipsychotics) for at least 2 weeks during the current depressive episode; (7) Able to understand and sign the informed consent form.

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The 20th ward of general psychiatric department
Coordinator of this site? Confirm its status
TianjinChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.