Viborg Sellers (insectrefund07)
ABSTRACT Objective NeuroStar® Advanced Therapy System is a transcranial magnetic stimulation (TMS) device with FDA-clearance for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. With TMS, magnetic pulses are transmitted into the brain. Though the exact mechanism of action is unknown, it is postulated that resulting neuronal depolarization and changes in brain functional activity may be associated with various physiologic changes that lead to relief of depression in the indicated population. The type of magnetic field generated with TMS is not intended to induce a seizure during therapeutic use, but unintentional seizures have been reported during TMS treatment.No seizures were reported with the use of the NeuroStar® system in clinical trials conducted prior to FDA clearance. The estimated risk of seizure in the NeuroStar® label is approximately 1 in 30,000 treatments or 1 in 1,000 the rate of seizures during TMS treatment with the NeuroStar® appears to be lower than the rate that is published in the NeuroStar® Advanced Therapy prescribing information. CONCLUSIONS Seizures that take place during TMS treatment with the NeuroStar® system are rare. The rate of seizures reported directly to Neuronetics, Inc. is lower than that included in the NeuroStar® prescribing information. Our literature review validated seizures during TMS treatment with the NeuroStar® system reported in published literature have described either non-epileptic events (syncope) or occurred with risk factors for seizure induction, such as other predisposing clinical factors or treatment parameters outside the guideline recommend "safe" ranges. FUNDING ACKNOWLEDGEMENTS Neuronetics, Inc.OBJECTIVE To assess the Patient Health Questionnaire (PHQ-9) as a predictor of relapse of depressive symptoms in treatment-resistant depression (TRD). buy Envonalkib METHOD Analysis included maintenance phase data from SUSTAIN-1 (NCT02493868), a randomized, double-blind, active-controlled study in TRD patients that evaluated efficacy of intranasal esketamine (ESK) + oral antidepressant (AD) vs AD + intranasal placebo in delaying relapse of depressive symptoms. A ≥50% reduction in initial symptom score and total score of ≤12 were considered as response and remission, respectively, using the Montgomery-Asberg Depression Rating Scale. PHQ-9 total score (range, 0-27), PHQ-2 total score (0-6), and individual items of the PHQ-9 (0-3) were examined as predictors of relapse. Data were collected every 2 weeks. Association between time-varying PHQ-9 and event of depression relapse was evaluated in Andersen-Gill Cox model. RESULTS Of 176 stable remitters, 63 had a relapse event (ESK+AD [n=24]; AD+placebo [n=39]). Of 121 stable responders, 50 had a relapse event (ESK+AD [n=16]; AD+placebo [n=34]). Among stable remitters, PHQ-9 total score (HR; 95% CI [1.12; 1.04-1.21]) and PHQ-2 total score (1.58; 1.25-1.99) were associated with relapse risk. PHQ-9 items #1 (loss of pleasure, 2.07; 1.38-3.09), #2 (feeling down, 2.18; 1.51-3.15), #4 (feeling tired, 1.54; 1.13-2.11), and #6 (negative self-view, 2.27; 1.41-3.66) were associated with relapse risk. PHQ-2 total scale yielded the smallest Akaike's Information Criterion among stable remitters and responders. CONCLUSION PHQ-9, PHQ-2 total scores or individual items may be useful for predicting relapse of depressive symptoms among stable TRD patients. FUNDING ACKNOWLEDGEMENTS This study was sponsored by Janssen Research and Development, LLC.STUDY OBJECTIVES In light of the opioid crisis, less attention has been focused on the long-term misuse of benzodiazepines (BZD) for anxiety and sleep disorders. The purpose of this study was to determine the sustainability of positive results (an 80% decrease in BZD prescribing) following a deprescribing intervention with primary care providers working with a low-income population a
