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RCT of At-Home tDCS for Depression in Pregnancy

NCT05097586 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-05-28

No results posted yet for this study

Summary

This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum

Conditions

Interventions

DEVICE

active tDCS

2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks

OTHER

workbook

Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state

DEVICE

sham tDCS

Sham stimulation in which the current turns off after 30 seconds in a slow ramp down that mirrors sensory adaptation in ongoing stimulation, delivered in 15 sessions lasting 30 minutes each over 3 weeks

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Sophie Grigoriadis, MD, PhD · Sunnybrook Health Sciences Centre

  • Daniel Blumberger, MD, MSc · Centre for Addiction and Mental Health

  • Simone Vigod, MD, MSc · Women's College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2026-01-31
Completion
2027-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097586 on ClinicalTrials.gov