Double-Blind, Proof-of-Concept (POC) Trial of Low Field Magnetic Stimulation (LFMS) Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (TRD)
What is the purpose of this trial?
This double-blind, sham-controlled, sequential parallel comparison design study of the acute efficacy of LFMS in the treatment of adults with MDD with TRD, will be carried out in the four proposed core RAPID sites (MGH, Yale University, Mount Sinai School of Medicine, and University of Texas Southwestern). A minimum of 60 eligible subjects with treatment-resistant MDD, male or female age 18-65, will be randomly assigned to double-blind treatment with LFMS 20 min/day for four days, sham treatment 20 min/day for four days, or sham 20 min/day for 2 days followed by LFMS treatment 20 min/day for two days, using the sequential parallel comparison design (randomization 1:1:1). The primary objective is to demonstrate that LFMS is superior to sham therapy in the acute treatment of patients with TRD, when added to ongoing and stable antidepressant therapy. Superiority will be demonstrated by a statistically significant greater decrease (p<0.05, 2-sided) on the 6-item Hamilton Rating Scale for Depression (HAM-D-6) (Hamilton, 1960; Bech et al, 1981; O'Sullivan et al, 1997) total score for patients receiving LFMS versus sham therapy, using the sequential parallel comparison design (SPCD). To test the primary hypothesis, the SPCD will pool the data from both phases following 48 hours of active versus sham treatment. Human clinical studies have been performed to date with LFMS under a nonsignificant risk (NSR) determination from the FDA, which allows trials to be performed without the submission of an IDE application. The NSR designation reflects the FDA¿s assessment that LFMS is a safe technique for clinical trial purposes.
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- National Institute of Mental Health
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