NCT06812923 TACS on High-inflammatory and Refractory Depression
| NCT ID | NCT06812923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Anding Hospital |
| Condition | Treatment Resistant Depression (TRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06812923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Treatment Resistant Depression (TRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06812923 currently recruiting?
Yes, NCT06812923 is actively recruiting participants. Contact the research team at yangchh@tjmhc.com for enrollment information.
Where is the NCT06812923 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06812923 clinical trial?
NCT06812923 is sponsored by Tianjin Anding Hospital. The trial plans to enroll 52 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.