NCT07274917

Stereotactic Radiotherapy Treatment for Treatment-resistant Depression

The Efficacy and Safety of Stereotactic Radiotherapy for Treatment-Resistant Depression: An Open-Label Exploratory Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study is an clinical trial aimed at evaluating the effectiveness and safety of stereotactic radiotherapy for treatment-resistant depression

Detailed description

Treatment-Resistant Depression (TRD) generally refers to patients with depression who have received at least two antidepressants with different mechanisms of action, at adequate doses and for sufficient durations, but have shown poor or no response. TRD is difficult to treat and usually has a poor prognosis, seriously affecting the normal life of patients and their families. One of the imaging manifestations of TRD patients is abnormal functional activity of the subgenual anterior cingulate cortex (sgACC). The direct clinical intervention method for this area is to implant a deep brain stimulator through an invasive approach. However, this intervention method has a low risk-benefit ratio and is poorly accepted by patients. Radiation is a widely used clinical intervention technique. By focusing rays from multiple angles, it can generate high-energy rays in a local area of the human brain for ablation. This technique is typically used for targeted ablation of tumors and has the advantage of high precision. Recently, breakthrough research has found that radiotherapy can be applied in the field of psychiatry. In experiments with doses of 10Gy and 20Gy, researchers observed an increase in the standard uptake value of the irradiated target area compared to the contralateral brain region in PET images of the subjects, suggesting that radiotherapy can up-regulate glucose metabolism levels without killing neurons at low doses. These clinical studies suggest that stereotactic radiotherapy can safely regulate brain function. Based on this, this project aims to explore the safety, efficacy, and biological mechanisms of low-dose radiotherapy targeting the sgACC in the treatment of TRD.

Conditions

• Treatment-Resistant Depression
• Depressive Disorder

Interventions

Type	Name	Description
DEVICE	ZAP-X	The individualized bilateral sgACC template will be imported into the ZAP-X treatment planning system. For left and right sgACC targets, the treatment plan will be automatically generated with the following set-up. The treatment will be carried out on two consecutive days.

Timeline

• Start date: 2026-01-26
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-12-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study