Dancho Dilkov1, Emily R Hawken2, Emil Kaludiev1, Roumen Milev3. 1. Department of Psychiatry, Military Medical Academy, Sofia, Bulgaria. 2. Department of Psychiatry, Queen's University, Kingston, ON, Canada.; Department of Biomedical and Molecular Sciences, Queen's University, Kingston, ON, Canada. 3. Department of Psychiatry, Queen's University, Kingston, ON, Canada.. Electronic address: roumen.milev@queensu.ca.
Abstract
BACKGROUND: Up to 50% of people with GAD fail to respond to first-line pharmacotherapies for generalized anxiety disorder (GAD), partly due to poor treatment compliance rates and partly due to the complex physiology underlying GAD. Thus, new non-invasive techniques, like repetitive transcranial magnetic stimulation (rTMS) are being investigated. METHODS:Participants were recruited from two different mood disorder sites: Kingston, Ontario, Canada and Sofia, Bulgaria. Hamilton Anxiety Rating Scale (HARS) scores were reported from patients diagnosed with GAD following treatment with high-frequency (20Hz) rTMS applied to the right dorsal lateral prefrontal cortex (DLPFC). RESULTS: By the end of 25 rTMS treatments, the ACTIVE (n=15) treatment group showed a clinically significant reduction in the HARS scores compared to the SHAM (n=25) group. Hedge's g at visit 4 (following 25 rTMS treatments) was 2.1 between ACTIVE and SHAM treatments. Furthermore, at 2 and 4weeks follow-up (after the end of treatment) HARS scores of the ACTIVE group remained stable and even slightly improved, demonstrating a sustained effect of the response. LIMITATIONS: Relatively small sample size of the ACTIVE group as well as the SHAM procedure may limit the generalizability of the results. CONCLUSIONS: Thus, participants receiving rTMS treatment showed a clinically significant decrease in reported anxiety symptoms as measured by the HARS. rTMS may be a treatment options for patients treatment refractory to pharmacotherapies. www.clinicaltrials.gov: NCT00616447.
RCT Entities:
BACKGROUND: Up to 50% of people with GAD fail to respond to first-line pharmacotherapies for generalized anxiety disorder (GAD), partly due to poor treatment compliance rates and partly due to the complex physiology underlying GAD. Thus, new non-invasive techniques, like repetitive transcranial magnetic stimulation (rTMS) are being investigated. METHODS:Participants were recruited from two different mood disorder sites: Kingston, Ontario, Canada and Sofia, Bulgaria. Hamilton Anxiety Rating Scale (HARS) scores were reported from patients diagnosed with GAD following treatment with high-frequency (20Hz) rTMS applied to the right dorsal lateral prefrontal cortex (DLPFC). RESULTS: By the end of 25 rTMS treatments, the ACTIVE (n=15) treatment group showed a clinically significant reduction in the HARS scores compared to the SHAM (n=25) group. Hedge's g at visit 4 (following 25 rTMS treatments) was 2.1 between ACTIVE and SHAM treatments. Furthermore, at 2 and 4weeks follow-up (after the end of treatment) HARS scores of the ACTIVE group remained stable and even slightly improved, demonstrating a sustained effect of the response. LIMITATIONS: Relatively small sample size of the ACTIVE group as well as the SHAM procedure may limit the generalizability of the results. CONCLUSIONS: Thus, participants receiving rTMS treatment showed a clinically significant decrease in reported anxiety symptoms as measured by the HARS. rTMS may be a treatment options for patients treatment refractory to pharmacotherapies. www.clinicaltrials.gov: NCT00616447.
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