Optimizing treatment for major depressive disorder using SAINT®

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

This study is testing if the SAINT® Neuromodulation System can help adults with Major Depressive Disorder who haven't found relief from other medications.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Magnus Medical (industry)
• Locations: 7 sites (Costa Mesa, California and 6 other locations)
• Trial ID: NCT05819021 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of the SAINT® Neuromodulation System in treating adults with Major Depressive Disorder (MDD) who have not responded to previous antidepressant medications. Participants will undergo 10 treatments over 5 days, and their progress will be assessed using the Clinical Global Impressions-Improvement (CGI-I) scale at the end of the treatment period. The study will involve up to 1000 subjects across multiple centers and is expected to last approximately 4 years, with each participant's involvement lasting about 1 year.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have not achieved satisfactory improvement from prior antidepressant treatments for major depressive disorder.

Not a fit: Patients with contraindications to TMS or those at high risk of suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with treatment-resistant major depressive disorder.

How similar studies have performed: Other studies utilizing neuromodulation techniques have shown promise in treating major depressive disorder, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Costa Mesa, California and 6 other locations

• BrainHealth Solutions — Costa Mesa, California, United States (RECRUITING)
• LA TMS — Los Angeles, California, United States (ACTIVE_NOT_RECRUITING)
• Integral TMS — Sunnyvale, California, United States (ACTIVE_NOT_RECRUITING)
• Acacial Research Center — Sunnyvale, California, United States (COMPLETED)
• Boston Precision Neurotherapeutics — Natick, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
• Fermata — Brooklyn, New York, United States (RECRUITING)
• Seattle Neuropsychiatric Treatment Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Jessica Hawkins

Conditions: Major Depressive Disorder, Depression, Treatment Resistant Depression