title: Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial.
abstract: BACKGROUND
  Women with depression in pregnancy are faced with difficult treatment decisions. Untreated, antenatal depression has serious negative implications for mothers and children. While antidepressant drug treatment is likely to improve depressive symptoms, it crosses the placenta and may pose risks to the unborn child. Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression, without impacting any other brain areas, and without inducing changes to heart rate, blood pressure or core body temperature. The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy, although it has never previously been evaluated in this population.
  
  
  METHODS
  We describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger, multicentre efficacy study. Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication. Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks. Women sit upright during treatment and receive obstetrical monitoring prior to, during and after each treatment session. Depressive symptoms, treatment acceptability, and pregnancy outcomes are assessed at baseline (prior to randomization), at the end of each treatment week, every four weeks post-treatment until delivery, and at 4 and 12 weeks postpartum.
  
  
  CONCLUSIONS
  Transcranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy. This protocol allows for assessment of the feasibility of, acceptability of and adherence with a clinical trial protocol to administer this treatment to pregnant women with moderate to severe depression. Results from this pilot study will guide the development of a larger multicentre trial to definitively test the efficacy and safety of transcranial direct current stimulation for pregnant women with depression.
  
  
  BACKGROUND
  Clinical Trials Gov NCT02116127.
authors.affiliation: Women's College Hospital and Research Institute, 76 Grenville Street, Toronto, ON M5S 1B1, Canada. simone.vigod@wchospital.ca.
authors.forename: Simone
authors.initials: S
authors.lastname: Vigod
authors.forename: Cindy-Lee
authors.initials: CL
authors.lastname: Dennis
authors.forename: Zafiris
authors.initials: Z
authors.lastname: Daskalakis
authors.forename: Kellie
authors.initials: K
authors.lastname: Murphy
authors.forename: Joel
authors.initials: J
authors.lastname: Ray
authors.forename: Tim
authors.initials: T
authors.lastname: Oberlander
authors.forename: Sarah
authors.initials: S
authors.lastname: Somerton
authors.forename: Neesha
authors.initials: N
authors.lastname: Hussain-Shamsy
authors.forename: Daniel
authors.initials: D
authors.lastname: Blumberger
mesh_terms: D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D005865:Gestational Age; D006801:Humans; D009864:Ontario; D010865:Pilot Projects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D065908:Transcranial Direct Current Stimulation / Q000009:adverse effects; D016896:Treatment Outcome