NCT05819021Active, not recruiting
Open Label Optimization Study
An Open Label Optimization Study to Assess the Effectiveness of the SAINT® Neuromodulation System (NMS) to Treat Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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®
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 4 Apr 2023
- Start date
- 6 Apr 2023
- Primary completion date
- 15 Oct 2026
- Lead sponsor
- Magnus Medical
- Diseases
- Depression
- NCT number
- NCT05819021
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 6 Apr 2023 to the primary completion date, 15 Oct 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have any contraindication to receiving an MRI
Other
- Have any contraindication to TMS (section 2 User Manual).
- Participants with an abnormal brain MRI as determined by PI, study physician or designee.
- Deemed by the PI, study physician or designee to be a high risk of suicide or has made a suicide attempt within the last 6 months.
- Treatment dose with cortical depth adjustment is greater than 120% motor threshold and cannot be completed.
Who the study is looking for
- Adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
- Confirmed primary clinical diagnosis of major depressive disorder (MDD) without psychotic features consistent with DSM-V criteria.
- No medical conditions that would preclude the safe use of TMS.
- Primary psychiatrist has determined TMS to be an appropriate clinical option.
- Able to provide consent and comply with all study requirements.
- Negative pregnancy test at the intended time of SAINT™ 5-day acute course treatment and agreement to use effective birth control during SAINT® acute therapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fermata Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| BrainHealth Solutions Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| LA TMS Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Boston Precision Neurotherapeutics Coordinator of this site? Confirm its status | Natick | United States | Unknown status |
| Seattle Neuropsychiatric Treatment Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Integral TMS Coordinator of this site? Confirm its status | Sunnyvale | United States | Unknown status |
| Acacia Research Center Coordinator of this site? Confirm its status | Sunnyvale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.