Abstract
BackgroundWomen 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/designWe 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.DiscussionTranscranial 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.Trial registrationClinical Trials Gov NCT02116127.
Highlights
Women with depression in pregnancy are faced with difficult treatment decisions
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
Summary
Depression complicates up to 10% of pregnancies, more than gestational diabetes, hypertension or pre-eclampsia [1]. We presented on depression in pregnancy and on tDCS to both the mental health and obstetrical departments in the respective institutions to ensure that a wide range of providers seeing these patients had a good understanding of the reasons for treating depression and of the proposed treatment with tDCS These presentations led us to develop, at the suggestion of the practitioners, an information sheet for practitioners that could help guide their discussions. This includes recognition that provision of appropriate mental health care requires dialogue between all providers and care systems involved, during vulnerable periods of time, such as during a pregnancy This pilot RCT will allow us to assess the feasibility of a trial protocol for administering tDCS among pregnant women with moderate to severe depression. NH-S is the current research coordinator and contributed to the development of the study design and trial schema She assisted with drafting the manuscript, edited the manuscript and approved the final version for publication. He contributed to the drafting and editing of the manuscript and approved the final version for publication
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