Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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