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NCT06477276Completed

Amygdala TIS for Depression

A Multicenter, Randomized, Controlled, Double-Blind Trial on the Efficacy and Safety of Amygdala Temporal Interference Stimulation for the Treatment of Depression.

Source: ClinicalTrials.gov · Last updated 19 Jun 2025

Brief summary (registry, in English)

The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.

Status (registry)
Completed
Study type
Interventional
Enrollment
92 (actual)
First submitted
20 Jun 2024
Start date
24 Jul 2024
Primary completion date
1 May 2025
Lead sponsor
Ruijin Hospital
Diseases
Depression
NCT number
NCT06477276

What you commit to

  • Study type: Interventional
  • Participants enrolled: 92
  • From 24 Jul 2024 to the primary completion date, 1 May 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants must not have a history of seizures or prior episodes of epilepsy;
  • Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);

Other illness

  • Eligible participants must not have a history of psychiatric disorders such as schizophrenia, as judged by the investigator, which may impact the evaluation of the study's efficacy;
  • The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
  • Participants must not have a diagnosis of organic brain disease nor a history of significant cranial trauma or neurosurgical intervention;

Other

  • The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;
  • Pregnant or breastfeeding;
  • Participants who are concurrently engaged in other clinical interventional trials;
  • Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied.

Who the study is looking for

  • Participants must be aged between 18 and 65, with no gender restrictions;
  • A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
  • HAMD-17 score of 17 or higher;
  • Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
  • Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol and provide their signature on the informed consent form.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai East Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Ruijin hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University)
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.