Journal: Journal of Clinical Medicine (2022)
Authors: Gaby S. Pell, Tal Harmelech, Yiftach Roth, Aron Tendler
Comorbid anxiety is common in patients with major depressive disorder (MDD), and these disorders may share a common underlying pathophysiology. Up to 85% of patients with depression experience significant anxiety symptoms, and comorbid depression occurs in up to 90% of subjects with anxiety disorders.
The authors analyzed data from a previous multicenter trial, an independent head-to-head study, and late-life depression randomized controlled trial to determine if Deep TMS with the H1 Coil is effective in treating comorbid anxiety symptoms in MDD.
Data from the three trials using the H1 Coil to treat MDD were evaluated for effectiveness to treat comorbid anxiety. The primary measure was the adjusted Hamilton Depression Rating Scale (HDRS) Anxiety/Somatization (HDRS-A/S) factor score at baseline after 4 weeks of treatment. A secondary endpoint was change in the Hamilton Anxiety Rating Scale (HAM-A). The proportion of subjects who presented with anxious depression was calculated as baseline of HDRS-A/S≥7. All patients were treated with H1 Coil at 18Hz, 2s trains, 20s inter-train intervals (1980 pulses/day).
Active Deep TMS compared with sham showed significantly larger reductions in HDRS A/S (d=0.424, p<0.0118). These effects were durable for >16 weeks (d=0.434, p<0.004 and d=0.652, p<0.0144 for HDRS A/S and HAM-A, respectively).
The pooled effect size between the three RCTs using the BrainsWay H1 Coil was 0.55, which compares favorably to alternative treatments.
In contrast to previously reported studies using Traditional TMS and medication for which anxiety has been shown to be a negative predictor of effectiveness, higher baseline anxiety was found to be predictive of successful outcome for the H1 Coil treatment.
Deep TMS with the H1 Coil is an effective and robust treatment for anxious depression, a challenging and frequently refractory condition. Using the H1 Coil, better or equal improvement was observed compared to anxiolytic medication, and better improvement was seen than Traditional TMS.
Unlike alternative treatments, the outcome does not appear to be adversely affected by high baseline anxiety levels, which has been a limiting factor with existing treatments such as Traditional TMS and anxiolytic medication.