Cheng-Ta Li1, Chih-Ming Cheng2, Mu-Hong Chen2, Chi-Hung Juan3, Pei-Chi Tu2, Ya-Mei Bai2, Jia-Shyun Jeng2, Wei-Chen Lin2, Shih-Jen Tsai2, Tung-Ping Su4. 1. Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Brain Research Center, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan. Electronic address: ctil2@vghtpe.gov.tw. 2. Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan. 3. Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan. 4. Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Brain Research Center, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan.
Abstract
BACKGROUND:Prolonged intermittent theta burst stimulation (piTBS) with triple doses of the standard protocol is an updated form of repetitive transcranial magnetic stimulation, and it is an effective add-on intervention for major depressive disorder. In the present study, our objective was to investigate the antidepressant efficacy of piTBS monotherapy. Efficacy between the standard 5-cm method and magnetic resonance imaging (MRI)-guided coil positioning to the left dorsolateral prefrontal cortex method was also compared. METHODS: In the present double-blind, randomized, sham-controlled trial, 105 patients with recurrent depression who exhibited no responses to at least one adequate antidepressant treatment for the prevailing episode were assigned randomly to one of three groups: piTBS monotherapy (n = 35), repetitive transcranial magnetic stimulation monotherapy (n = 35), or sham stimulation (n = 35). The acute treatment period was 2 weeks. Half of the patients were randomized to MRI navigation in each group. RESULTS: No serious adverse events were observed. The piTBS group exhibited significantly greater decreases in depression scores than the sham group at week 2 (-40.0% vs. -13.9%; p < .001 after correcting for multiple comparisons by Bonferroni [effect size (Cohen's d) = 1.12]), and the odds ratio for responses was high. The MRI navigation method (-32.4%) did not yield better antidepressant effects than the standard method (-40.6%). Brain stimulation and 17-item Hamilton Depression Rating Scale changes in the first week were the most important variables for predicting antidepressant responses. CONCLUSIONS: Left prefrontal piTBS monotherapy is effective for the treatment of recurrent depression, and the MRI-guided method of coil targeting is not better than the standard method.
RCT Entities:
BACKGROUND: Prolonged intermittent theta burst stimulation (piTBS) with triple doses of the standard protocol is an updated form of repetitive transcranial magnetic stimulation, and it is an effective add-on intervention for major depressive disorder. In the present study, our objective was to investigate the antidepressant efficacy of piTBS monotherapy. Efficacy between the standard 5-cm method and magnetic resonance imaging (MRI)-guided coil positioning to the left dorsolateral prefrontal cortex method was also compared. METHODS: In the present double-blind, randomized, sham-controlled trial, 105 patients with recurrent depression who exhibited no responses to at least one adequate antidepressant treatment for the prevailing episode were assigned randomly to one of three groups: piTBS monotherapy (n = 35), repetitive transcranial magnetic stimulation monotherapy (n = 35), or sham stimulation (n = 35). The acute treatment period was 2 weeks. Half of the patients were randomized to MRI navigation in each group. RESULTS: No serious adverse events were observed. The piTBS group exhibited significantly greater decreases in depression scores than the sham group at week 2 (-40.0% vs. -13.9%; p < .001 after correcting for multiple comparisons by Bonferroni [effect size (Cohen's d) = 1.12]), and the odds ratio for responses was high. The MRI navigation method (-32.4%) did not yield better antidepressant effects than the standard method (-40.6%). Brain stimulation and 17-item Hamilton Depression Rating Scale changes in the first week were the most important variables for predicting antidepressant responses. CONCLUSIONS: Left prefrontal piTBS monotherapy is effective for the treatment of recurrent depression, and the MRI-guided method of coil targeting is not better than the standard method.
Authors: Diego Freitas Tavares; Paulo Suen; Carla Garcia Rodrigues Dos Santos; Doris Hupfeld Moreno; Leandro Da Costa Lane Valiengo; Izio Klein; Lucas Borrione; Pamela Marques Forte; André R Brunoni; Ricardo Alberto Moreno Journal: Neuropsychopharmacology Date: 2021-06-30 Impact factor: 7.853