Depression DisordersNCT06891326
Efficacy and Safety of tACS for Depression: a Multicenter RCT Study
A study testing active tACS in people with Depression Disorders, run by Ruijin Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Disorders
- What is being tested?
- active tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesChina
- Study dates
- 8 Oct 2024to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of depressive disorder;
- Age ranges between 18 and 65 years;
- HDRS-17 score equals to or above 8;
- No medical history/Under stable antidepressant treatment in one month;
Who cannot join
- Combination of other psychotic disorders and neurological diseases;
- History of invasive brain surgeries;
- Non-invasive neurostimulation treatments within 3 months;
- Physical condition that may endanger patients' safety during the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, 200025
Yunhao Wu, 0086-021-15021638398, wuyh_2022@163.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Yunhao WU, 86-21-15021638398, wuyh1996@icloud.com
About this study
Official title: Efficacy and Safety of Transcranial Alternating Current Stimulation for Depression: a Multicenter Randomized Controlled Trial Study
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.
- Conditions
- Depression Disorders
- Being tested
- sham transcranial Alternating Current Stimulation, active tACS
- Keywords
- tACS, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham transcranial Alternating Current StimulationDevice
we use fade-in, short-stimulation, fade-out (FSF) stimulation pattern, with 60s-long fade-in/out periods, 2.0mA peak current at the beginning and the end of stimulation session
active tACSDevice
The active tACS protocol lasted for 40 min of continuous sine-wave stimulation with the frequency of 10Hz and an amplitude ranging from 1.5mA to 2.0mA, adjusted according to the tolerability among individuals.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Not described Receives: Device: sham transcranial Alternating Current Stimulation |
| Treatment group | Active comparator | Not described Receives: Device: active tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
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.
Measured: 4 weeks after the intervention
Secondary outcomes (1)
Adverse events
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.
Measured: 8 weeks, when the study is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start8 Oct 2024
- Primary completion8 Sep 2025 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center, Shandong Mental Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891326
- Sponsor's protocol ID
- 20240913
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wu Y, Ning C, Shi L, Wang J, Ye K, Shen Z, Wang Y, Wang D, Guo H, Qiu X, Pan Y, Paerhati H, Li D, Mo Y, Wan J, Hu H, Cao Y, Sun B, Lv X. A multicenter randomized clinical trial of portable transcranial alternating current stimulation for major depressive disorder. NPJ Digit Med. 2026 Mar 28;9(1):392. doi: 10.1038/s41746-026-02575-9.
PubMed 41904320
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcranial Alternating Current Stimulation for Depression: a Multicenter Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT06891326
- Acronym / sponsor ID
- 20240913
- Conditions
- Depression Disorders
- Keywords
- tACS, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center, Shandong Mental Health Center
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 8 Sep 2025 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: sham transcranial Alternating Current Stimulation |
| Treatment group | Active comparator | Device: active tACS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of depressive disorder;
- Age ranges between 18 and 65 years;
- HDRS-17 score equals to or above 8;
- No medical history/Under stable antidepressant treatment in one month;
Key exclusion criteria (4 listed)
- Combination of other psychotic disorders and neurological diseases;
- History of invasive brain surgeries;
- Non-invasive neurostimulation treatments within 3 months;
- Physical condition that may endanger patients' safety during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham transcranial Alternating Current Stimulationwe use fade-in, short-stimulation, fade-out (FSF) stimulation pattern, with 60s-long fade-in/out periods, 2.0mA peak current at the beginning and the end of stimulation session | Device | Control group |
| active tACSThe active tACS protocol lasted for 40 min of continuous sine-wave stimulation with the frequency of 10Hz and an amplitude ranging from 1.5mA to 2.0mA, adjusted according to the tolerability among individuals. | Device | Treatment group |
Primary outcome
Clinical remission
Time frame: 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.
1 secondary outcome
Adverse events
Time frame: 8 weeks, when the study is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Derived from this study: PubMed 41904320Wu Y, Ning C, Shi L, Wang J, Ye K, Shen Z, Wang Y, Wang D, Guo H, Qiu X, Pan Y, Paerhati H, Li D, Mo Y, Wan J, Hu H, Cao Y, Sun B, Lv X. A multicenter randomized clinical trial of portable transcranial alternating current stimulation for major depressive disorder. NPJ Digit Med. 2026 Mar 28;9(1):392. doi: 10.1038/s41746-026-02575-9.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tACS in people with Depression Disorders, run by Ruijin Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunhao Wu (008602115021638398, wuyh_2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: 4 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06891326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.