Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2023-04-06
2027-04-15
Brief Summary
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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
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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
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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SAINT® Stimulation
All participants will receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Magnus Medical
INDUSTRY
Responsible Party
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Locations
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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
Boston Precision Neurotherapeutics
Natick, Massachusetts, United States
Fermata
Brooklyn, New York, United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, United States
Countries
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Other Identifiers
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CLN-0107
Identifier Type: -
Identifier Source: org_study_id