Temporally Interfering Electrical Stimulation for Major Depressive Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized, sham-controlled trial compares single-target TI stimulation of the right A1, dual-target TI stimulation of the right A1 and right DLPFC, and sham stimulation over two weeks. Each participant receives ten treatment visits with 20 minutes of stimulation per visit. The goal is to determine the safety and efficacy of TI stimulation for reducing depressive symptoms in adults with current MDD. Participants must meet DSM-5 criteria for MDD, have moderate severity on the HAM-D, and be between 18 and 65 years old. The study uses standardized assessments and stringent eligibility criteria to ensure reliable results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for MDD, confirmed independently by two psychiatrists;
2. Currently experiencing a depressive episode;
3. Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17;
4. Aged between 18-65 years;
5. No restrictions on sex or gender;
6. Attained at least junior high school education; lower education permitted if cognitive capacity is confirmed by a physician;
7. Normal or corrected-to-normal vision and normal hearing;
8. No use of antidepressant within two weeks prior to enrollment, or ongoing antidepressant treatment judged by a psychiatrist to be in a stable treatment phase;
9. Ability to read and understand informed consent and self-report assessment scales;
10. Willingness to participate in the study, with written informed consent provided by the participant or a legal guardian.

Exclusion Criteria:

1. History of any psychiatric disorder other than MDD;
2. History of traumatic brain injury or coma;
3. History of organic brain disease or severe systemic medical illness;
4. History of cochlear implants, pacemakers, or other implanted brain devices;
5. History of epileptic seizures or family history of epilepsy;
6. Obvious suicidal or impulsive violent behavior;
7. Receipt of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within the past six months;
8. History of alcohol use disorder or use of other psychoactive substances;
9. Participation in other interventional clinical trials;
10. Any condition precluding informed consent or compliance with study procedures.

Where it's running

• Fuzhou Neuropsychiatric Hospital Affiliated to Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• Tianjin Anding Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xianyun Kang
• Email: xianyunkang@tju.edu.cn
• Phone: +862283612122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.