TACS on High-inflammatory and Refractory Depression

NCT06812923 | Recruiting DMC

• 1 other identifier: TJAD-tACS15
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depression (TRD); Inflammation

Keywords

treatment resistant depression; transcranial Alternating Current Stimulation; C-reactive protein

Outcome Measures

Primary Outcomes (1)

• the change in scores of HAMD-17 after treatment

  4 weeks (at the end week 4)

Secondary Outcomes (3)

• the change in scores of HAMD-17 after follow up

  12 weeks (at the end week 12)

• the change in levels of serum biomarkers after treatment and follow up

  4 and 12 weeks (at the end week 4 and 12)

• the change in power of EEG activity in specific brain regions after treatment and follow up

  4 and 12 weeks (at the end week 4 and 12)

Study Arms (2)

tACS group

EXPERIMENTAL

participants receive tACS (15mA、77.5Hz tACS) treatment for 20 times (5 times a week, four weeks totally), with ongoing antidepressant treatment.

Device: transcranial Alternating Current Stimulation (tACS)

Sham group

SHAM COMPARATOR

participants receive sham stimulation for 20 times (5 times a week, four weeks totally), with ongoing antidepressant treatment.

Device: Sham stimulation

Interventions

transcranial Alternating Current Stimulation (tACS) DEVICE

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

tACS group

Sham stimulation DEVICE

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

Sham group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: identify according to the biological sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

The 20th ward of general psychiatric department

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Inflammation

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Chenghao Yang, PhD

CONTACT

0086-022-88188299; yangchh@tjmhc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: within 2 years after the whole study finished

Locations

CN (1)