An observational study in Major Depressive Disorder, sponsored by Magnus Medical. Active, not recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Magnus Medical · Observational
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®
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).
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 131 across 400 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Magnus Medical is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: TMS
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.
Time frame: End of Stimulation Day 5
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
Time frame: 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"
Time frame: 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.
Time frame: 3, 6, 9, 12 month follow up visit
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
Time frame: Consent through 12 month follow up visit
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Oct 2026, 42 months after the start.
Of 29 industry-sponsored observational studies under Depressive Disorder, Major, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 33. This study's planned 42 months is above that.
Counting every sponsor, half of 150 studies reached it within 38 months; a quarter within 21 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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