Major Depressive Disorder (MDDNCT07829575

Amygdala-Targeted Transcranial Temporal Interference Stimulation for Major Depressive Disorder: A Randomized Sham-Controlled Trial of Clinical Efficacy and Neurobiological Mechanisms

A study testing Transcranial Temporal Interference Stimulation in people with Major Depressive Disorder (MDD, run by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of amygdala-targeted transcranial temporal interference stimulation (tTIS) in adults with major depressive disorder (MDD) and to explore its potential neurobiological mechanisms. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Major Depressive Disorder (MDD
What is being tested?: Transcranial Temporal Interference Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteChina
Study dates: 20 Oct 2026to 30 Dec 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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Aged 18 to 55 years, inclusive, with no restriction on sex.
Diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as determined by a study physician.
A 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥17 at screening/baseline.
The antidepressant medication regimen must remain stable from at least 30 days before signing the informed consent form through the study period.
In the judgment of the investigator, the participant or their legally authorized representative is able to understand the purpose and procedures of the study, comply with the study protocol, and provide written informed consent.

Who cannot join

A history of other psychiatric disorders, neurological disorders, or substance abuse that, in the investigator's judgment, may interfere with the assessment of treatment efficacy.
A history of epilepsy, seizures, or convulsive episodes.
Presence of intracranial metallic foreign bodies or metallic implants in or near the heart.
Presence of organic brain disease, or a history of severe head injury or cranial surgery.
Receipt of electroconvulsive therapy (ECT) or other physical treatments, such as transcranial magnetic stimulation (TMS), within the 30 days before enrollment.
An unstable psychiatric condition or significant suicide risk, as assessed by the investigator.

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Women who are pregnant or breastfeeding.
Current participation in another interventional clinical trial.
Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jingjing Huang contact

021-68306699*1222

huangjingjing18@tongji.edu.cn

China1 site

Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality, 201204
Jingjing Huang, 021-68306699*1222, huangjingjing18@tongji.edu.cn

Other trials in China

About this study

Official title: Amygdala-targeted Temporal Interference Stimulation for Major Depressive Disorder。

The main questions this study aims to answer are:

Whether active amygdala-targeted tTIS reduces depressive symptoms compared with sham stimulation.

Whether tTIS produces changes in amygdala-related neural activity and functional brain networks that are associated with clinical improvement.

Participants will be randomly assigned to receive either active tTIS or sham stimulation. They will complete a course of stimulation sessions and undergo clinical assessments before and after the intervention. Neuroimaging assessments will also be performed to investigate treatment-related changes in the amygdala and associated brain networks.

Conditions: Major Depressive Disorder (MDD
Being tested: Transcranial Temporal Interference Stimulation, Sham Transcranial Temporal Interference Stimulation
Keywords: Transcranial Temporal Interference Stimulation, Major Depressive Disorde, Amygdala, Neuromodulation, Neuroimaging
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.

Transcranial Temporal Interference StimulationDevice
Active transcranial temporal interference stimulation (tTIS) will be delivered using two pairs of scalp electrodes. Two high-frequency alternating currents with slightly different carrier frequencies will be applied to generate a low-frequency temporal interference envelope within the targeted amygdala region. Electrode placement and stimulation parameters will be determined according to the study protocol and individualized electric-field modeling when applicable. Participants assigned to the active group will receive 10 stimulation sessions, with each session lasting 30 minutes, according to the predefined treatment schedule.
Sham Transcranial Temporal Interference StimulationDevice
Participants assigned to the sham group will undergo the same electrode placement and treatment procedures as the active stimulation group. Sham stimulation will include brief ramp-up and ramp-down periods to mimic the initial sensory experience of active stimulation, without delivering continuous therapeutic stimulation during the remainder of the session.

Study groups in NCT07829575
Study group	Role	What they receive
Active tTIS	Experimental	Not described Receives: Device: Transcranial Temporal Interference Stimulation
Sham tTIS	Sham comparator	Not described Receives: Device: Sham Transcranial Temporal Interference Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated scale used to assess the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity. The primary outcome is the change in HAMD-17 total score from baseline to the end of the 10-session intervention.
Measured: Baseline; after 10 stimulation sessions (30 minutes per session; end of Week 2)

Secondary outcomes (11)

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale used to assess the severity of depressive symptoms. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity. Changes in MADRS total score from baseline will be assessed following treatment and during follow-up.
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score Across Treatment and Follow-up
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
The Hamilton Anxiety Rating Scale (HAMA) is a clinician-rated scale used to assess the severity of anxiety symptoms. Total scores range from 0 to 56, with higher scores indicating greater anxiety severity. Changes in HAMA total score from baseline will be assessed following treatment and during follow-up.
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
The Snaith-Hamilton Pleasure Scale (SHAPS) is used to assess anhedonia and reduced capacity to experience pleasure. Changes in SHAPS score from baseline will be used to evaluate treatment-related changes in hedonic functioning.
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported measure of sleep quality and sleep disturbances. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Changes in PSQI global score from baseline will be assessed following treatment and during follow-up.
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Domain Scores
The WHOQOL-BREF is a self-reported measure of quality of life across physical health, psychological health, social relationships, and environmental domains. Higher domain scores indicate better perceived quality of life. Changes in domain scores from baseline will be assessed after treatment and during follow-up.
Measured: Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
The Generalized Anxiety Disorder-7 (GAD-7) is a self-reported measure of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity. Changes in GAD-7 score from baseline will be assessed following treatment and during follow-up.
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-reported measure used to assess the severity of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Changes in PHQ-9 total score from baseline will be assessed following treatment and during follow-up.
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Cognitive Performance Assessed by the THINC-integrated Tool (THINC-it)
The THINC-integrated Tool (THINC-it) is a computerized cognitive assessment designed to evaluate subjective and objective cognitive functioning, including attention, processing speed, working memory, and executive function. Changes in THINC-it performance from baseline will be assessed following treatment and during follow-up.
Measured: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Temporal Experience of Pleasure Scale (TEPS) Score
The Temporal Experience of Pleasure Scale (TEPS) is a self-reported measure of anticipatory and consummatory pleasure. Changes in TEPS scores from baseline will be explored to assess treatment-related changes in reward-related emotional experience.
Measured: Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Emotion Regulation Questionnaire (ERQ) Score
The Emotion Regulation Questionnaire (ERQ) assesses habitual use of cognitive reappraisal and expressive suppression as emotion regulation strategies. Changes in ERQ scores from baseline will be explored following treatment and during follow-up.
Measured: Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202630 Dec 2027

First posted21 Sep 2026
Study start20 Oct 2026 (estimated)
Primary completion30 Dec 2027 (estimated)
Study completion30 Dec 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 Disorder (MDDStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07829575
Sponsor's protocol ID: PDJW_2026_MDD
Status last verified: Sep 2026
First submitted: 3 Sep 2026
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: Yes
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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Amygdala-targeted Temporal Interference Stimulation for Major Depressive Disorder。
ClinicalTrials.gov ID: NCT07829575
Acronym / sponsor ID: PDJW_2026_MDD
Conditions: Major Depressive Disorder (MDD
Keywords: Transcranial Temporal Interference Stimulation, Major Depressive Disorde, Amygdala, Neuromodulation, Neuroimaging
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji UniversityUniversity, hospital or other
Study start: 20 Oct 2026 (estimated)
Primary completion: 30 Dec 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 21 Sep 2026 (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.

The main questions this study aims to answer are:

Whether active amygdala-targeted tTIS reduces depressive symptoms compared with sham stimulation.

Whether tTIS produces changes in amygdala-related neural activity and functional brain networks that are associated with clinical improvement.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active tTIS	Experimental	Device: Transcranial Temporal Interference Stimulation
Sham tTIS	Sham comparator	Device: Sham Transcranial Temporal Interference Stimulation

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Aged 18 to 55 years, inclusive, with no restriction on sex.
Diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as determined by a study physician.
A 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥17 at screening/baseline.
The antidepressant medication regimen must remain stable from at least 30 days before signing the informed consent form through the study period.
In the judgment of the investigator, the participant or their legally authorized representative is able to understand the purpose and procedures of the study, comply with the study protocol, and provide written informed consent.

Key exclusion criteria (9 listed)

A history of other psychiatric disorders, neurological disorders, or substance abuse that, in the investigator's judgment, may interfere with the assessment of treatment efficacy.
A history of epilepsy, seizures, or convulsive episodes.
Presence of intracranial metallic foreign bodies or metallic implants in or near the heart.
Presence of organic brain disease, or a history of severe head injury or cranial surgery.
Receipt of electroconvulsive therapy (ECT) or other physical treatments, such as transcranial magnetic stimulation (TMS), within the 30 days before enrollment.

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
Transcranial Temporal Interference StimulationActive transcranial temporal interference stimulation (tTIS) will be delivered using two pairs of scalp electrodes. Two high-frequency alternating currents with slightly different carrier frequencies will be applied to generate a low-frequency temporal interference envelope within the targeted amygdala region. Electrode placement and stimulation parameters will be determined according to the study protocol and individualized electric-field modeling when applicable. Participants assigned to the active group will receive 10 stimulation sessions, with each session lasting 30 minutes, according to the predefined treatment schedule.	Device	Active tTIS
Sham Transcranial Temporal Interference StimulationParticipants assigned to the sham group will undergo the same electrode placement and treatment procedures as the active stimulation group. Sham stimulation will include brief ramp-up and ramp-down periods to mimic the initial sensory experience of active stimulation, without delivering continuous therapeutic stimulation during the remainder of the session.	Device	Sham tTIS

Primary outcome

Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Time frame: Baseline; after 10 stimulation sessions (30 minutes per session; end of Week 2)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated scale used to assess the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity. The primary outcome is the change in HAMD-17 total score from baseline to the end of the 10-session intervention.

11 secondary outcomes

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score Across Treatment and Follow-up
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Domain Scores
Time frame: Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.
Change in Cognitive Performance Assessed by the THINC-integrated Tool (THINC-it)
Time frame: Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Temporal Experience of Pleasure Scale (TEPS) Score
Time frame: Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.
Change in Emotion Regulation Questionnaire (ERQ) Score
Time frame: Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.

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 21 Sep 2026.
Individual participant dataSharing planned: No

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.

Jingjing Huang contact

021-68306699*1222

huangjingjing18@tongji.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 21 Sep 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. 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?

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 Jingjing Huang (021-68306699*1222, huangjingjing18@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score (time frame: Baseline; after 10 stimulation sessions (30 minutes per session; end of Week 2)). 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 NCT07829575.

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 21 Sep 2026.