Open Label Optimization Study (OLO)

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

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®

Study Overview

• Status: Active, not recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: SAINT® Neuromodulation System (NMS)

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).

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92626
      • BrainHealth Solutions
    • Los Angeles, California, United States, 90025
      • LA TMS
    • Sunnyvale, California, United States, 94085
      • Integral TMS
    • Sunnyvale, California, United States, 94087
      • Acacia Research Center
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Boston Precision Neurotherapeutics
  • New York
    • Brooklyn, New York, United States, 11249
      • Fermata
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Neuropsychiatric Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who fulfill all the inclusion criteria and none of the exclusion criteria will be enrolled into the study. Each participant will read and sign the IRB approved informed consent form prior to any screening or study procedures being performed. This open-label study involves an evaluation of the safety and effectiveness of an acute course of the SAINT® NMS.

Description

Inclusion Criteria:

1. Adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
2. Confirmed primary clinical diagnosis of major depressive disorder (MDD) without psychotic features consistent with DSM-V criteria.
3. No medical conditions that would preclude the safe use of TMS.
4. Primary psychiatrist has determined TMS to be an appropriate clinical option.
5. Able to provide consent and comply with all study requirements.
6. 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.

Exclusion Criteria:

1. Have any contraindication to TMS (section 2 User Manual).
2. Have any contraindication to receiving an MRI
3. Participants with an abnormal brain MRI as determined by PI, study physician or designee.
4. 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.
5. Treatment dose with cortical depth adjustment is greater than 120% motor threshold and cannot be completed.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SAINT® Stimulation; All participants will receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy.

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.; Other Names: TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Clinical Global Impression Improvement Scale (CGI-I) score at the end of treatment (Day 5 SAINT® therapy)	Clinical Global Impression-Improvement (CGI-I) score is based on a scale from zero (0) - Not Assessed to seven (7) Very Much Worse with lower scores showing improvement and higher scores showing little or no improvement.	End of Stimulation Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS) score change from baseline to cessation of stimulation in comparison with bioimaging assessments MADRS score change from baseline to cessation of stimulation in comparison with bioimaging assessments	The rating is based on a clinical interview. Questions are asked using scales from zero (0) to six (6) with lower scores showing a better outcome and higher scores showing a worse outcome	Baseline to End Stimulation Day 5
Cambridge Brain Science Tools assessment score change in comparison with change in MADRS scores from baseline to cessation of stimulation	Assess aspects of cognition including reasoning, memory, attention and verbal ability on an online platform. Scores are automatically calculated on a scale from zero (0) to one hundred (100) and zero (0) to negative one hundred (-100) with positive numbers being associated with "Best" and negative numbers being associated with "Worst"	Baseline to End of Stimulation Day 5
To test the durability of the antidepressant effect by assessing the Clinical Global Impression Severity Scale (CGI-S) after cessation of stimulation	The Clinical Global Impression-Severity (CGI-S) is a brief clinician assessment that rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score is based on a scale from zero (0) - Not Assessed to seven (7) Very Much Worse with lower scores showing improvement and higher scores showing little or no improvement.	3, 6, 9, 12 month follow up visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse Event Reporting assessment for causality and severity	Any untoward medical occurrence in a participant treated with an investigational device, without regard to the possibility of a causal relationship with this treatment. Adverse events will be recorded and followed through all follow-up visits	Consent through 12 month follow up visit

Collaborators and Investigators

• Sponsor: Magnus Medical

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Major Depressive Disorder; Treatment Resistant Depression
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: CLN-0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No