Condition: Major Depressive Disorder · Major Depressive Episode · Suicidal Ideation · Sponsor: Magnus Medical
This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) Technology on the neural circuitry of suicidal cognitions in psychiatrically hospitalized patients with Major Depressive Disorder (MDD) and active suicidal ideation (SI). This will be accomplished by applying the MNS with SAINT to a customized target within the left dorsolateral prefrontal cortex (L-DLPFC) identified with fMRI for five consecutive days and measuring resting-state functional connectivity (RS FC) between the subgenual anterior cingulate cortex (sgACC) and the default mode network (DMN) at baseline and immediate-post visit. The relationship between changes in RS FC and changes in both Explicit and Implicit Suicidal Cognitions (ESC and ISC, respectively) will be determined. This study will also determine the relationship between changes in RS FC in neural networks underlying mediators of suicidal cognitions and changes in such mediators with active versus sham SAINT.
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| University of Iowa | Iowa City, Iowa, United States | — |
| Weill Cornell Medicine | Manhattan, New York, United States | — |
| Medical University of South Carolina (MUSC) | Charleston, South Carolina, United States | — |
| University of Texas, Austin | Austin, Texas, United States | — |
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Source record: clinicaltrials.gov/study/NCT03693105