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A clinical randomized controlled study on the treatment of adolescent depression by amygdala time-interferometric electrical stimulation

A clinical randomized controlled study on the treatment of adolescent depression by amygdala time-interferometric electrical stimulation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109598
Enrollment
Unknown
Registered
2025-09-22
Start date
2025-09-24
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Adolescent MDD

Interventions

real group:real TIs group
sham group:sham TIs group

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Age: 12-18 years old; 2.Meet the MDD diagnostic criteria for DSM-V; 3.The score of HAMD-17>=17; 4.Right-handed; 5.Physical examination, medical history, vital signs, routine blood, urine and stool tests, liver and kidney function, electrolytes, electrocardiogram, electroencephalogram and other indicators are all normal; 6.After fully understanding the safety of transcranial electrical stimulation, I am willing to actively cooperate with the treatment and have both myself and my family sign informed consent;

Exclusion criteria

Exclusion criteria: 1.Other physical therapies, such as electroconvulsive shock, transcranial magnetic stimulation, transcranial electrical stimulation, etc., were received within 3 months before enrollment; 2.Those with a history of severe physical illness and depression caused by other psychoactive substances and non-dependent substances; 3.Subjects who have metal or electronic devices implanted in their bodies, such as intracranial metal foreign bodies, cochlear implants, pacemakers and stents, etc; 4.There is a risk of epileptic seizures, with a history of craniocerebral diseases, head trauma, alcohol abuse, abnormal electroencephalograms, MRI evidence of abnormal brain structure, or a family history of epilepsy; 5.There has been a history of attempted suicide in the past two weeks; 6.The types of drugs have remained unchanged and the dosages have been stable in the past two weeks;

Design outcomes

Primary

MeasureTime frame
Change of 17-item Hamilton Depression Rating Scale (HAMD-17) scores;

Secondary

MeasureTime frame
Multimodal neuroimaging features, including structural and functional magnetic resonance imaging (MRI), functional near-infrared spectroscopy (fNIRS), transcranial magnetic stimulation-evoked motor po;Adverse Event Scale;Clinical symptom changes were assessed using standardized clinical rating scales;Changes in relevant indicators related to cognition based on scales and computer behavior tasks;

Countries

China

Contacts

Public ContactXiaoli Liu

Affiliated Kangning Hospital of Ningbo University

1206207800@qq.com+86 574 26302510

Outcome results

None listed

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