Phase
Condition
Depression
Affective Disorders
Depression (Adult And Geriatric)
Treatment
SAINT® Neuromodulation System (NMS)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult males or females, 18 and older, who have failed to receive satisfactoryimprovement from prior antidepressant medication in the current episode.
Confirmed primary clinical diagnosis of major depressive disorder (MDD) withoutpsychotic 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 treatmentand agreement to use effective birth control during SAINT® acute therapy.
Exclusion
Exclusion Criteria:
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 ordesignee.
Deemed by the PI, study physician or designee to be a high risk of suicide or hasmade a suicide attempt within the last 6 months.
Treatment dose with cortical depth adjustment is greater than 120% motor thresholdand cannot be completed.
Study Design
Study Description
Connect with a study center
BrainHealth Solutions
Costa Mesa, California 92626
United StatesActive - Recruiting
LA TMS
Los Angeles, California 90025
United StatesSite Not Available
Acacial Research Center
Sunnyvale, California 94087
United StatesCompleted
Integral TMS
Sunnyvale, California 94085
United StatesActive - Recruiting
Boston Precision Neurotherapeutics
Natick, Massachusetts 01760
United StatesSite Not Available
Fermata
Brooklyn, New York 11249
United StatesActive - Recruiting
Seattle Neuropsychiatric Treatment Center
Seattle, Washington 98104
United StatesActive - Recruiting
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