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
1 other identifier
observational
1,000
1 country
7
Brief 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®
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2023
CompletedStudy Start
First participant enrolled
April 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2027
December 24, 2025
June 1, 2025
3.5 years
April 4, 2023
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
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
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
3, 6, 9, 12 month follow up visit
Other Outcomes (1)
Safety - Adverse Event Reporting assessment for causality and severity
Consent through 12 month follow up visit
Study Arms (1)
SAINT® Stimulation
All participants will receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy.
Interventions
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.
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Magnus Medicallead
Study Sites (7)
BrainHealth Solutions
Costa Mesa, California, 92626, United States
LA TMS
Los Angeles, California, 90025, United States
Integral TMS
Sunnyvale, California, 94085, United States
Acacia Research Center
Sunnyvale, California, 94087, United States
Boston Precision Neurotherapeutics
Natick, Massachusetts, 01760, United States
Fermata
Brooklyn, New York, 11249, United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
April 19, 2023
Study Start
April 6, 2023
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
April 15, 2027
Last Updated
December 24, 2025
Record last verified: 2025-06