Transcranial stimulation for treatment-resistant depression with high inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial investigates the effectiveness of transcranial alternating current stimulation (tACS) in patients aged 18 to 55 with treatment-resistant depression (TRD) and elevated inflammatory markers. Over a 12-week period, participants will receive either active tACS or sham stimulation, with assessments of depressive symptoms and biological markers conducted at baseline, during, and after the intervention. The study aims to clarify the impact of tACS on depressive symptoms and explore underlying mechanisms of action related to inflammation. A total of 52 patients will be enrolled and monitored throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Where it's running

• The 20th ward of general psychiatric department
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Chenghao Yang, PhD
• Email: yangchh@tjmhc.com
• Phone: 0086-022-88188299

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

  This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.

  Recruiting at 10 sites Fondation FondaMental · Besançon and 16 other locations · NCT07881016

• DHEA add-on to standard antidepressants for treatment-resistant depression

  This trial tests whether adding 100 mg/day of DHEA to patients’ current antidepressant treatment helps people with treatment-resistant depression feel better.

  Recruiting at 9 sites Phase 3 Charite University, Berlin, Germany · Berlin, State of Berlin and 8 other locations · NCT07843927

• One-Day cTBS Over the Precuneus and iTBS Over the Left PFC for Treatment-Resistant Depression

  This study tests whether a one-day accelerated TMS session targeting the precuneus or the left dorsolateral prefrontal cortex can reduce depressive symptoms in adults with treatment-resistant depression, compared with sham stimulation.

  Recruiting Mclean Hospital · Belmont, Massachusetts · NCT07758010

• Predicting Treatment Response in Psychiatric Disorders Using Biological Markers

  This study tests whether biological markers can predict which patients with psychiatric conditions will respond to treatment.

  Recruiting Centre Hospitalier St Anne · Paris · NCT07741981

• Cannabidiol Oil as an Add-on for Treatment-Resistant Major Depression

  This study tests whether full-spectrum CBD oil added to standard antidepressants can help adults with treatment-resistant major depression.

  Recruiting Phase 1/2 Universidade do Sul de Santa Catarina · Tubarão, Santa Catarina · NCT07696871

• Biomarker-guided antidepressant choice to see if rTMS or ketamine works best for you

  This study tests whether brain and behavior markers can help match people with major depression to either rTMS or ketamine to see which works better for them.

  Recruiting at 2 sites Phase 4 Weill Medical College of Cornell University · New York, New York and 1 other locations · NCT07680140

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.