Simone N Vigod1, Kellie E Murphy2, Cindy-Lee Dennis3, Tim F Oberlander4, Joel G Ray3, Zafiris J Daskalakis5, Daniel M Blumberger5. 1. University of Toronto, Toronto, Ontario, Canada; Women's College Hospital and Research Institute, Toronto, Ontario, Canada. Electronic address: simone.vigod@wchospital.ca. 2. University of Toronto, Toronto, Ontario, Canada; Sinai Health System, Toronto, Ontario, Canada. 3. University of Toronto, Toronto, Ontario, Canada; St. Michael's Hospital, Li Ka Shing Knowledge Translation Institute, Toronto, Ontario, Canada. 4. BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada. 5. University of Toronto, Toronto, Ontario, Canada; Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Abstract
BACKGROUND:Depression in pregnancy negatively affects maternal-child health. Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation treatment for depression, has not been evaluated in pregnancy. OBJECTIVE: To conduct a pilot randomized controlled trial (RCT) to evaluate tDCS for antenatal depression. METHODS: In this pilot RCT in Toronto, Ontario (October 2014 to December 2016), adult pregnant women 14-32 weeks gestation with major depressive disorder who had declined antidepressant medication were considered for inclusion. Participants were randomly assigned 1:1 to tDCS or sham-control. Active tDCS comprised 30-min sessions of 2 mAmp direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 3 weeks. Sham was administered similarly, but with current turned off after 30 s. Main outcomes were feasibility, acceptability, and protocol adherence. Maternal Montgomery Asperg Depression Rating Scale (MADRS) was measured post-treatment and at 4 and 12 weeks postpartum. RESULTS: Of 20 women randomized, 16 completed treatment and provided data (124 tDCS, 122 sham sessions). Views of treatment were positive with no serious adverse events. Post-treatment estimated marginal mean MADRS scores were 11.8 (standard error, SE 2.66) for tDCS and 15.4 (SE 2.51) for sham (p = 0.34). At 4 weeks postpartum, 75.0% of tDCS women were remitted versus 12.5% sham-control (p = 0.04). CONCLUSIONS: Results support proceeding to a definitive RCT to evaluate tDCS for antenatal depression. The preliminary efficacy estimates immediately post-treatment and in the postpartum, are encouraging with respect to the potential use of tDCS to improve treatment rates in this population. The trial was registered at: clinical trials.gov (NCT02116127).
RCT Entities:
BACKGROUND:Depression in pregnancy negatively affects maternal-child health. Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation treatment for depression, has not been evaluated in pregnancy. OBJECTIVE: To conduct a pilot randomized controlled trial (RCT) to evaluate tDCS for antenatal depression. METHODS: In this pilot RCT in Toronto, Ontario (October 2014 to December 2016), adult pregnant women 14-32 weeks gestation with major depressive disorder who had declined antidepressant medication were considered for inclusion. Participants were randomly assigned 1:1 to tDCS or sham-control. Active tDCS comprised 30-min sessions of 2 mAmp direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 3 weeks. Sham was administered similarly, but with current turned off after 30 s. Main outcomes were feasibility, acceptability, and protocol adherence. Maternal Montgomery Asperg Depression Rating Scale (MADRS) was measured post-treatment and at 4 and 12 weeks postpartum. RESULTS: Of 20 women randomized, 16 completed treatment and provided data (124 tDCS, 122 sham sessions). Views of treatment were positive with no serious adverse events. Post-treatment estimated marginal mean MADRS scores were 11.8 (standard error, SE 2.66) for tDCS and 15.4 (SE 2.51) for sham (p = 0.34). At 4 weeks postpartum, 75.0% of tDCS women were remitted versus 12.5% sham-control (p = 0.04). CONCLUSIONS: Results support proceeding to a definitive RCT to evaluate tDCS for antenatal depression. The preliminary efficacy estimates immediately post-treatment and in the postpartum, are encouraging with respect to the potential use of tDCS to improve treatment rates in this population. The trial was registered at: clinical trials.gov (NCT02116127).