Marc J Dubin1, Irena P Ilieva2, Zhi-De Deng3, Jeena Thomas3, Ashly Cochran2, Kamilla Kravets2, Benjamin D Brody2, Paul J Christos4, James H Kocsis2, Conor Liston5, Faith M Gunning6. 1. Department of Psychiatry, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA; Feil Family Brain and Mind Research Institute, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA. Electronic address: mrd9035@med.cornell.edu. 2. Department of Psychiatry, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA. 3. Noninvasive Neuromodulation Unit, Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD 20892, USA. 4. Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA. 5. Department of Psychiatry, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA; Sackler Institute for Developmental Psychobiology, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA; Feil Family Brain and Mind Research Institute, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA. 6. Department of Psychiatry, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA; Institute of Geriatric Psychiatry, Weill Cornell Medical College-New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10065, USA.
Abstract
BACKGROUND:Low field magnetic stimulation is a potentially rapid-acting treatment for depression with mood-enhancing effects in as little as one 20-min session. The most convincing data for LFMS has come from treating bipolar depression. We examined whether LFMS also has rapid mood-enhancing effects in treatment-resistant major depressive disorder, and whether these effects are dose-dependent. OBJECTIVE/HYPOTHESIS: We hypothesized that a single 20-min session of LFMS would reduce depressive symptom severity and that the magnitude of this change would be greater after three 20-min sessions than after a single 20-min session. METHODS: In a double-blind randomized controlled trial, 30 participants (age 21-65) with treatment-resistant depression were randomized to three 20-min active or sham LFMS treatments with 48 h between treatments. Response was assessed immediately following LFMS treatment using the 6-item Hamilton Depression Rating Scale (HAMD-6), the Positive and Negative Affect Scale (PANAS) and the Visual Analog Scale. RESULTS: Following the 3rd session of LFMS, the effect of LFMS on VAS and HAMD-6 was superior to sham (F (1, 24) = 7.45, p = 0.03, Bonferroni-Holm corrected; F (1, 22) = 6.92, p = 0.03, Bonferroni-Holm corrected, respectively). There were no differences between sham and LFMS following the initial or second session with the effect not becoming significant until after the third session. CONCLUSIONS: Three 20-min LFMS sessions were required for active LFMS to have a mood-enhancing effect for individuals with treatment-resistant depression. As this effect may be transient, future work should address dosing schedules of longer treatment courses as well as biomarker-based targeting of LFMS to optimize patient selection and treatment outcomes.
RCT Entities:
BACKGROUND: Low field magnetic stimulation is a potentially rapid-acting treatment for depression with mood-enhancing effects in as little as one 20-min session. The most convincing data for LFMS has come from treating bipolar depression. We examined whether LFMS also has rapid mood-enhancing effects in treatment-resistant major depressive disorder, and whether these effects are dose-dependent. OBJECTIVE/HYPOTHESIS: We hypothesized that a single 20-min session of LFMS would reduce depressive symptom severity and that the magnitude of this change would be greater after three 20-min sessions than after a single 20-min session. METHODS: In a double-blind randomized controlled trial, 30 participants (age 21-65) with treatment-resistant depression were randomized to three 20-min active or sham LFMS treatments with 48 h between treatments. Response was assessed immediately following LFMS treatment using the 6-item Hamilton Depression Rating Scale (HAMD-6), the Positive and Negative Affect Scale (PANAS) and the Visual Analog Scale. RESULTS: Following the 3rd session of LFMS, the effect of LFMS on VAS and HAMD-6 was superior to sham (F (1, 24) = 7.45, p = 0.03, Bonferroni-Holm corrected; F (1, 22) = 6.92, p = 0.03, Bonferroni-Holm corrected, respectively). There were no differences between sham and LFMS following the initial or second session with the effect not becoming significant until after the third session. CONCLUSIONS: Three 20-min LFMS sessions were required for active LFMS to have a mood-enhancing effect for individuals with treatment-resistant depression. As this effect may be transient, future work should address dosing schedules of longer treatment courses as well as biomarker-based targeting of LFMS to optimize patient selection and treatment outcomes.
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