Skip to content

Exploratory Study on the Efficacy and Neuroimaging Mechanisms of Time-Windowed Interferential Transcranial Electrical Stimulation Targeting the Amygdala or Medial Forebrain Bundle for the Treatment of Depression

Exploratory Study on the Efficacy and Neuroimaging Mechanisms of Time-Windowed Interferential Transcranial Electrical Stimulation Targeting the Amygdala or Medial Forebrain Bundle for the Treatment of Depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109227
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Major depressive disorder

Interventions

AMY Active Group:TI stimulation
slMFB Active Group:TI stimulation
shame group:TI shame stimulation

Sponsors

Beijing An Ding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Outpatients or inpatients aged between 18 and 65 years (inclusive), of any gender; 2.Diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), presenting with either a single or recurrent episode, without psychotic features; 3.A Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20 at both screening and baseline; 4.Patients must have been treated with at least one of the following antidepressants for >= 4 weeks prior to enrollment. Combination therapy is allowed with no more than two antidepressants, and the dosage must remain unchanged from enrollment to the end of study participation. Acceptable medications include: Selective serotonin reuptake inhibitors (SSRIs) Serotonin-norepinephrine reuptake inhibitors (SNRIs) Other commonly prescribed antidepressants. Additionally, the following medications are permitted for sleep support: Estazolam, Zolpidem Tartrate, Zopiclone, Eszopiclone, Dexzopiclone, and Zaleplon. 5.Able to understand and voluntarily agree to participate in the study, comply with the treatment protocol, and sign the written informed consent in person;

Exclusion criteria

Exclusion criteria: 1.Current or past diagnosis of other psychiatric disorders according to the DSM-; 2.Participation in other interventional neuromo; 3.Individuals deemed by the investigator to be at high risk for suicide at the time of screening; 4.Contraindications to MRI, including but not limited to intracranial metal implants, pacemakers, or cochlear implants; 5.Presence of skull defects (e.g., cranial cavities or fractures), inability to tolerate adverse effects, treatment-resistant epilepsy, or any other severe somatic illness that, in the investigator’s opinion, may interfere with the study intervention or outcomes; 6.Pregnant women; 7.Any other condition that, in the investigator’s judgment, makes the subject unsuitable for participation in the study;

Design outcomes

Primary

MeasureTime frame
MADRS Score Reduction;

Secondary

MeasureTime frame
HAMA Score Reduction;Cognitive;VAS and IMS Score Reduction;QIDS-SR Score Reduction;YMSR Score Reduction;C-SSRS Score Reduction;SAS Score Reduction;

Countries

China

Contacts

Public ContactZhi Yang

Beijing An Ding Hospital, Capital Medical University

yangz@mail.ccmu.edu.cn+86 18611710840

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026