RCT of At-Home tDCS for Depression in Pregnancy

What this study 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

Who can join (things the study team will check)

✅ You may be able to join if…

• Adult, ≥18 years of age
• Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization
• In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)
• Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use
• No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment

🚫 You may not be able to join if…

• Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
• Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
• Bipolar disorder as assessed by MINI International Neuropsychiatric Interview
• Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview
• Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia/eclampsia in current pregnancy or neurologic illness or seizure history
• Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
• Metal implants in cranium or any electrical implants
• Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS
• Visibly non-intact skin/rash on scalp areas at stimulation electrode sites
• Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English

Where this trial is running

• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
• Women's College Hospital, Toronto, Ontario, Canada

Who to contact

Simoe Vigod · 4163236400 · simone.vigod@wchospital.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05097586.