Efficacy and Safety of tACS for Depression: a Multicenter RCT Study

Not Applicable

Recruiting

• Conditions: Depression Disorders

• Registration Number: NCT06891326
• Lead Sponsor: Ruijin Hospital

Brief Summary

Transcranial alternating current stimulation (tACS) is a promising non-invasive technique for major depression, because of its advantage of lower risks and expenses compared to other therapies such as deep brain stimulation, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. Randomized controlled trials (RCTs) of depression treated by tACS have been conducted but provided limited and incongruous results. We designed a multi-center RCT to evaluate the efficacy and safety of tACS for depression.

Eligible participants will be patients diagnosed with depression (HDRS-17≥8), aged 18 to 65, and without other conditions that could interfere with the study. A total of 72 participants will be recruited from 4 clinic centers. Participants will be randomized 1:1 to active tACS or sham stimulation group. The study staff and the participants are blinded to the randomization results. Stimulating electrodes will be placed on the scalp corresponding to bilateral dorsolateral prefrontal cortex (DLPFC) using frequency of 10Hz and amplitude of 1.5 to 2.0 mA. The intervention will last for 4 weeks, containing 20 40-minute sessions in total. Another 4-week observation will be followed by the end of the intervention. Participants will receive assessments at baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the study begins. Psychological scales are used for the evaluation of their mental and quality of life. Besides, electroencephalogram (EEG) recording and magnetic resonance imaging (MRI) scans will also be performed to quantitatively measure the neural activities as well as the functional connectivity changes within the depression-related circuits.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-29
• Study Start: 2024-10-08
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-09-08
• Study Completion: 2026-10-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Clinical diagnosis of depressive disorder;
2. Age ranges between 18 and 65 years;
3. HDRS-17 score equals to or above 8;
4. No medical history/Under stable antidepressant treatment in one month;

Exclusion Criteria

1. Combination of other psychotic disorders and neurological diseases;
2. History of invasive brain surgeries;
3. Non-invasive neurostimulation treatments within 3 months;
4. Physical condition that may endanger patients' safety during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical remission	4 weeks after the intervention	The primary endpoint is defined as the decreased scores of Hamilton Depression Scale-17 (HDRS-17) at the 4-week follow-up compared to baseline scores. HDRS ranges from 0 to 68, with higher scores indicating more severe depression symptoms. The two-sample t-test is used to test the difference in score changes between the treatment group and control group at the 4-week follow-up visit point.

Secondary Outcome Measures

Name	Time	Method
Adverse events	8 weeks, when the study is completed	The adverse events will be reported by physicians at the 8-week follow-up visit, which items include the number of the events, the severe levels of each event, and its duration time.

Trial Locations

Locations (2)

Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China