Major Depressive DisorderNCT06826469
The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression
A study testing Temporal Interference Stimulation in people with Major Depressive Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 years old, right-handed, and completed nine years of compulsory education;
- Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression;
- HAMD-17≥18;
- Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks;
- The subject/ legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (TI).
Who cannot join
- Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
- Severe suicidal ideation or behavior;
- History of a serious physical illness or a disease that may affect the central nervous system;
- Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;
- Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);
- Those who have received or are receiving electroconvulsive therapy (ECT ), modified electroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments;
- Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.
- Conditions
- Major Depressive Disorder
- Being tested
- Temporal Interference Stimulation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference StimulationDevice
During the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is 3.64 mA+4.36 mA.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Specific electrode sites are customized for the subject through magnetic resonance scanning, the deep nucleus cluster to be stimulated-nucleus accumbens is calibrated through electric field simulation before treatment, and the stimulation target can be accurately positioned by stimulating the specific electrode sites of the subject during treatment. Receives: Device: Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale（HAMD-17)
The Hamilton Depression Scale（HAMD-17) was used to assess the extent of the patient's depressive episodes, with higher scores representing more severe depression, and this scale was used to monitor the patient's improvement in depression before and after treatment.
Measured: 0-5 days
Secondary outcomes (2)
Montgomery-Asberg Depression Rating Scale（MADRS）
The Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effectiveness of antidepressant treatment and to monitor changes in a patient's condition. The scale is a stand-alone scale whose ratings are based on a clinical interview with questioning about symptoms that leads to a rating of depression severity.
Measured: 0-5 days
Beck Scale for Suicide Ideation (BSS)
The Beck Suicidal Ideation Scale was used to assess the patients' suicidal ideation.
Measured: 0-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study startJun 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826469
- Sponsor's protocol ID
- IIT20240117C-R1
- Status last verified
- May 2026
- First submitted
- 29 Sep 2024
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression
- ClinicalTrials.gov ID
- NCT06826469
- Acronym / sponsor ID
- IIT20240117C-R1
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Feb 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.
This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Device: Temporal Interference StimulationSpecific electrode sites are customized for the subject through magnetic resonance scanning, the deep nucleus cluster to be stimulated-nucleus accumbens is calibrated through electric field simulation before treatment, and the stimulation target can be accurately positioned by stimulating the specific electrode sites of the subject during treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-50 years old, right-handed, and completed nine years of compulsory education;
- Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression;
- HAMD-17≥18;
- Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks;
- The subject/ legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (TI).
Key exclusion criteria (7 listed)
- Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
- Severe suicidal ideation or behavior;
- History of a serious physical illness or a disease that may affect the central nervous system;
- Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;
- Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);
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 |
|---|---|---|
| Temporal Interference StimulationDuring the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is 3.64 mA+4.36 mA. | Device | Temporal Interference Stimulation |
Primary outcome
Hamilton Depression Scale（HAMD-17)
Time frame: 0-5 days
The Hamilton Depression Scale（HAMD-17) was used to assess the extent of the patient's depressive episodes, with higher scores representing more severe depression, and this scale was used to monitor the patient's improvement in depression before and after treatment.
2 secondary outcomes
Montgomery-Asberg Depression Rating Scale（MADRS）
Time frame: 0-5 days
Beck Scale for Suicide Ideation (BSS)
Time frame: 0-5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference Stimulation in people with Major Depressive Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Hu (0571-87232984, dorhushaohua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale（HAMD-17) (time frame: 0-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.