Open Label Optimization Study

Running, not enrolling

Conditions studied: Major Depressive Disorder

In brief

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®

Key facts

Study ID

NCT05819021

Run by

Magnus Medical

People needed

1000

Starts

2023-04-06

Expected to finish

2027-04-15

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Have any contraindication to TMS (section 2 User Manual).
• Have any contraindication to receiving an MRI
• 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.

Where it is running

• Seattle Neuropsychiatric Treatment Center — Seattle, Washington, United States
• BrainHealth Solutions — Costa Mesa, California, United States
• LA TMS — Los Angeles, California, United States
• Integral TMS — Sunnyvale, California, United States
• Acacia Research Center — Sunnyvale, California, United States
• Boston Precision Neurotherapeutics — Natick, Massachusetts, United States
• Fermata — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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