Major Depressive DisorderOLONCT05819021
Open Label Optimization Study
An observational study of Major Depressive Disorder, run by Magnus Medical at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SAINT® Neuromodulation System (NMS)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Apr 2023to 15 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Fermata
Brooklyn, New York, 11249
BrainHealth Solutions
Costa Mesa, California, 92626
LA TMS
Los Angeles, California, 90025
Boston Precision Neurotherapeutics
Natick, Massachusetts, 01760
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
Integral TMS
Sunnyvale, California, 94085
Acacia Research Center
Sunnyvale, California, 94087
About this study
Official title: 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®
Read the 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).
- Conditions
- Major Depressive Disorder
- Being tested
- SAINT® Neuromodulation System (NMS)
- Keywords
- Major Depressive Disorder, Depression, Treatment Resistant Depression
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAINT® Neuromodulation System (NMS)Device
Also called TMS
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.
| Study group | Role | What they receive |
|---|---|---|
| SAINT® Stimulation | All participants will receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy. Receives: Device: SAINT® Neuromodulation System (NMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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"
Measured: 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.
Measured: 3, 6, 9, 12 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start6 Apr 2023
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magnus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819021
- Sponsor's protocol ID
- CLN-0107
- Acronym
- OLO
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Optimization Study to Assess the Effectiveness of the SAINT® Neuromodulation System (NMS) to Treat Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05819021
- Acronym / sponsor ID
- OLO / CLN-0107
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depression, Treatment Resistant Depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Magnus MedicalIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAINT® Stimulation | – | Device: SAINT® Neuromodulation System (NMS)All participants will receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAINT® Neuromodulation System (NMS)Also: TMSThe 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. | Device | SAINT® Stimulation |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Magnus Medical at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.