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Neuromodulation Device Use in Patients With Major Depressive Disorder

Medical Center of Aurora · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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depressionnaneuromodulation
Study the neuromodulation device in the treatment of Major Depressive Disorder and associated symptoms. In this study we use the Hamilton Depression Rating Scale (HAM-D), the Quality of Life Scale (QQLS), the Rumination Response Scale (RRS), the Brief Irritability Test (BIT), the Generalized Anxiety Disorder 7 Item Scale (GAD 7), and the Future Orientation Scale (FOS). This study was designed to mirror real life situations, and thus patients are not asked to stop their pharmaceutical treatments. Primary hypothesis for this study is: o Daily use of the device will decrease depressive symptoms as measured by HAM-D. Secondary hypotheses for these study are: * Daily use of the device will increase quality of life as measured by the QQLS. * Daily use of the device will decrease rumination as measured by the RRS. * Daily use of the device will decrease irritability as measured by the BIT. * Daily use of the device will increase future orientation as measured by the FOS. * Daily use of the device will decrease anxiety as measured by the GAD-7.
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