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Open Label Optimization Study

NCT05819021 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-12-24

No results posted yet for this study

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®

Conditions

Interventions

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.

Sponsors & Collaborators

  • Magnus Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-06
Primary Completion
2026-10-15
Completion
2027-04-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819021 on ClinicalTrials.gov