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

Ruijin Hospital3 sites in 1 country92 target enrollmentJuly 24, 2024

ConditionsMajor Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Ruijin Hospital
Enrollment: 92
Locations: 3
Primary Endpoint: Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 24, 2024

End Date

May 1, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

ZHANG CHENCHEHG

Clinical Neuroscience Center Deputy Director

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)

Time Frame: 4 weeks

Secondary Outcomes

Hamilton Depression Rating Scale (17-item version)(Baseline, 1 week, 4 weeks and 8 weeks)
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)(Baseline, 1 week and 8 weeks)
Snaith-Hamilton Pleasure Scale(Baseline, 1 week, 4 weeks and 8 weeks)
Hamilton Anxiety Rating Scale(Baseline, 4 weeks and 8 weeks)
Pittsburgh Sleep Quality Index(Baseline, 4 weeks and 8 weeks)
36-Item Short Form Health Survey(Baseline and 8 weeks)
World Health Organization Quality of Life Assessment - Brief Version(Baseline and 8 weeks)