Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05097586

RCT of At-Home tDCS for Depression in Pregnancy

Led by Women's College Hospital · Updated on 2025-05-28

156

Participants Needed

2

Research Sites

290 weeks

Total Duration

On this page

Sponsors

W

Women's College Hospital

Lead Sponsor

C

Centre for Addiction and Mental Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

RCT of At-Home tDCS for Depression in Pregnancy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult, 18 years of age or older
  • Singleton pregnancy between 12 and 32 weeks gestation at randomization
  • Currently experiencing a major depressive episode with moderate or greater severity (PHQ-9 score 60)
  • Assessed by a psychiatrist and offered antidepressant medication but declined use
  • No new depression treatments, psychological or pharmacological, in the 4 weeks before starting treatment
Not Eligible

You will not qualify if you...

  • Active alcohol or substance use disorder within the past 12 months
  • Active suicidality as assessed by Columbia Suicide Severity Rating Scale
  • Diagnosis of bipolar disorder
  • Diagnosis of schizophrenia or other psychotic disorder
  • Major unstable or life-threatening medical illness, pre-eclampsia/eclampsia, neurologic illness, or seizure history
  • Major congenital anomalies or obstetrical complications in current pregnancy
  • Presence of metal or electrical implants in the head
  • Use of benzodiazepines (except intermittent low-dose lorazepam 1 2mg per day) or anticonvulsants
  • Non-intact skin or rash at stimulation sites on the scalp
  • Unable to consent or complete study materials in English or French

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Not Yet Recruiting

2

Women's College Hospital

Toronto, Ontario, Canada, M5S1B2

Actively Recruiting

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Research Team

S

Simoe Vigod

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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