Depression Clinical Trial
Official title:
A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Dose Optimization Study of Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who are treatment resistant.
The primary objective of this study:
- To compare the relative efficacy, as measured by a change in the 6-item Hamilton Rating
Scale for Depression (HAM-D6), of 20 and 60 minutes of LFMS compared to sham (placebo)
in subjects with treatment resistant depression (TRD).
Secondary objectives:
- To determine if subjects with TRD may respond to 120 minutes of LFMS.
- To determine the persistence of response to LFMS therapy during the observation period.
- To evaluate the safety and tolerability of LFMS.
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