Clinical trial NCT05819021: Open Label Optimization Study
Official title: An Open Label Optimization Study to Assess the Effectiveness of the SAINT® Neuromodulation System (NMS) to Treat Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Treatment Resistant Depression
Lead sponsor: Magnus Medical
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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®

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).

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.

Primary outcomes:
measure: Mean Clinical Global Impression Improvement Scale (CGI-I) score at the end of treatment (Day 5 SAINT® therapy)
timeFrame: End of Stimulation Day 5
Secondary outcomes:
measure: 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
timeFrame: Baseline to End Stimulation Day 5
measure: Cambridge Brain Science Tools assessment score change in comparison with change in MADRS scores from baseline to cessation of stimulation
timeFrame: Baseline to End of Stimulation Day 5
measure: To test the durability of the antidepressant effect by assessing the Clinical Global Impression Severity Scale (CGI-S) after cessation of stimulation
timeFrame: 3, 6, 9, 12 month follow up visit
Other outcomes:
measure: Safety - Adverse Event Reporting assessment for causality and severity
timeFrame: Consent through 12 month follow up visit
Locations:
city: Costa Mesa
country: United States
facility: BrainHealth Solutions
state: California
city: Los Angeles
country: United States
facility: LA TMS
state: California
city: Sunnyvale
country: United States
facility: Integral TMS
state: California
city: Sunnyvale
country: United States
facility: Acacial Research Center
state: California
city: Natick
country: United States
facility: Boston Precision Neurotherapeutics
state: Massachusetts
city: Brooklyn
country: United States
facility: Fermata
state: New York
city: Seattle
country: United States
facility: Seattle Neuropsychiatric Treatment Center
state: Washington
Study officials:
References: