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Efficacy and safty study of temporal interference stimulation for major depressive disorder:A randomised controlled trial

Efficacy and safty study of temporal interference stimulation for major depressive disorder:A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124793
Enrollment
Unknown
Registered
2026-05-18
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

Control group:Healthy subjects with matched sex, age and education level were selected as the control group, and the exclusion criteria were the same as the depress

Sponsors

Tianjin Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–65 years, any sex; 2. Diagnosed with Major Depressive Disorder, current depressive episode by DSM-5 (first episode or recurrence); 3. HAMD-17 score >= 17; 4. Drug-naive or antidepressant regimen unchanged at least 4 weeks prior to consent through the study period; 5. Sufficient listening, speaking, reading, and comprehension ability to complete study assessments; 6. In the investigator’s judgment, able to understand the study purpose and procedures, comply with study requirements, and provide informed consent.

Exclusion criteria

Exclusion criteria: 1.Comorbid severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) or major neurological diseases (e.g., traumatic brain injury, post-neurosurgery); 2.History or family history of epilepsy or seizure disorders; 3.Presence of cranial/cardiac/internal metal implants or electronic devices; 4.Received ECT, TMS, or other physical treatments within 30 days; 5.HAMD-17 suicide item score >= 3; 6.Participation in other interventional clinical trials; 7.Pregnant, breastfeeding, or planning pregnancy during the study; 8.Other conditions deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
The 17-item Hamilton Depression Scale, HAMD-17;

Secondary

MeasureTime frame
Facial Emotion Recognition Test;Electroencephalogram;Resting state functional MRI;Scalp EEG signals for transcranial magnetic synchronization intervention, TMS-EEG;Thinc-it;Hamilton Anxiety Scale, HAMA;Clinical efficacy global scale, CGI-S/I;16-item rapid self-rating Depression Scale, QIDS-SR16;Sness-hamilton Pleasure Scale, SHAPS;Pittsburgh Sleep Quality Index scale, PSQI;Generalized Anxiety Disorder Scale, GAD-7;Adverse Event;Positive and Negative Affect Scale (PANAS), PANAS;Toronto Alexithymia Scale, TAS-20;36-item Short Form health Survey, SF-36;World Health Organization Health-related Quality of Life Measures short form, WHOQOL-BREF;

Countries

China

Contacts

Public ContactShen Li

Tianjin Anding Hospital

lishen@tmu.edu.cn+86 13752115075

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026