NCT05819021

Open Label Optimization Study

An Open Label Optimization Study to Assess the Effectiveness of the SAINT® Neuromodulation System (NMS) to Treat Major Depressive Disorder

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Magnus Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I at the end of the treatment Participants will receive 10 treatments per day for 5 days (M-F) of SAINT®

Detailed description

This is a prospective, multi-center, open-label study. Up to 1000 adult subjects, in a major depressive episode, who have failed to receive satisfactory improvement from a prior antidepressant medication in the current episode, are eligible to participate in this study if they are deemed to be appropriate candidates for TMS. Overall study duration is expected to be approximately 4 years. The study duration per subject is anticipated to be approximately 1 year. Hypothesis: The SAINT® Neuromodulation System will demonstrate effectiveness in the treatment of MDD as measured by CGI-I at the end of the treatment (cessation of stimulation).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	SAINT® Neuromodulation System (NMS)	The SAINT® NMS utilizes a type of accelerated iTBS delivered to a personalized treatment target derived from a functional MRI scan. SAINT® was designed to optimize the individual patient response to treatment. This novel approach to TMS is accomplished by focusing on three critical aspects of the treatment that drive effect. These aspects are personalized stimulation target, total course dose of stimulation, and neurophysiologically relevant stimulation pattern.

Timeline

• Start date: 2023-04-06
• Primary completion: 2026-10-15
• Completion: 2027-04-15
• First posted: 2023-04-19
• Last updated: 2025-12-24

Locations

7 sites across 1 country: United States