Open Label Optimization Study

N/AActive Not RecruitingNCT05819021

Magnus Medical1,000 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Major Depressive Disorder

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

BrainHealth Solutions

Costa Mesa, California, United States

LA TMS

Los Angeles, California, United States

Integral TMS

Sunnyvale, California, United States

Acacia Research Center

Sunnyvale, California, United States

Outcomes

Primary Outcomes

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

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

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.

Data from ClinicalTrials.gov

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