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OpenTrials
Active, Not Recruiting

NCT Number: NCT05819021

Open Label Optimization Study

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®

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BrainHealth Solutions, Costa Mesa, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SAINT® Neuromodulation System (NMS)

Device

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

Primary outcomes

  1. Mean Clinical Global Impression Improvement Scale (CGI-I) score at the end of treatment (Day 5 SAINT® therapy)

    Time frame: End of Stimulation Day 5

    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.

Secondary outcomes

  1. 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

    Time frame: Baseline to End Stimulation Day 5

    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

  2. Cambridge Brain Science Tools assessment score change in comparison with change in MADRS scores from baseline to cessation of stimulation

    Time frame: Baseline to End of Stimulation Day 5

    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"

  3. To test the durability of the antidepressant effect by assessing the Clinical Global Impression Severity Scale (CGI-S) after cessation of stimulation

    Time frame: 3, 6, 9, 12 month follow up visit

    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.

Other outcomes

  1. Safety - Adverse Event Reporting assessment for causality and severity

    Time frame: Consent through 12 month follow up visit

    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

Sponsors and collaborators

Lead sponsor

Magnus Medical

Industry

Registry information

Official study title

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

Acronym: OLO

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 19, 2023
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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