Transcranial stimulation for treatment-resistant depression with high inflammation
The Study on Effectiveness and Mechanisms of Transcranial Alternating Current Stimulation in Treating Increased Inflammatory Activity Refractory Depression
This study is testing if a type of brain stimulation can help young adults with treatment-resistant depression and high inflammation feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Tianjin Anding Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06812923 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 diagnosed with treatment-resistant depression and exhibiting high levels of inflammation.
Not a fit: Patients with a history of seizures, significant suicidal risk, or those who have undergone electroconvulsive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from treatment-resistant depression linked to high inflammatory activity.
How similar studies have performed: While the approach of using tACS for depression is emerging, similar studies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin, Tianjin Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.