Targeting the amygdala to treat depression

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

This study is testing a new non-invasive device to see if it can help people with major depression by targeting a specific part of the brain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 3 sites (Shanghai, Shanghai and 2 other locations)
• Trial ID: NCT06477276 on ClinicalTrials.gov

What this trial studies

This investigation utilizes a directed neuromodulation technique to target the right amygdala in order to evaluate its effectiveness in managing major depressive disorder. The intervention involves the use of a non-invasive device called Nervio-X, and the study will assess safety and efficacy through various measures of depressive symptoms, cognitive abilities, and daily functioning. Participants will be monitored for changes in their condition over the course of the intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with major depressive disorder and have a HAMD-17 score of 17 or higher.

Not a fit: Patients with a history of psychiatric disorders such as schizophrenia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new non-invasive treatment option for individuals suffering from major depressive disorder.

How similar studies have performed: While the approach of targeting the amygdala for depression treatment is innovative, similar neuromodulation techniques have shown promise in other studies, suggesting potential for success.

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.

Where this trial is running

Shanghai, Shanghai and 2 other locations

• Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)
• Shanghai East Hospital — Shanghai, China (Not_yet_recruiting)
• Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University) — Tianjin, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Yiru Fang, MD PhD — Ruijin Hospital
• Study coordinator: Chencheng Zhang, MD PhD

Conditions Major Depressive Disorder; Deep Brain Stimulation; Non-invasive; TI; Amygdala; Temporal Interference