At-home brain stimulation for depression during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, sham-controlled trial investigates the effectiveness of transcranial direct current stimulation (tDCS) in reducing symptoms of moderate to severe depression in pregnant individuals. A total of 156 participants will be enrolled, who will receive either active tDCS treatment or a sham control after an initial training session. Participants will self-administer the tDCS device at home for 30 minutes, five times a week over three weeks, with outcomes measured at various points during and after pregnancy. The study also includes a mixed methods process evaluation to assess the implementation and experience of the intervention.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Adult, ≥18 years of age
2. Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization
3. 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)
4. 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
5. No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment

Exclusion criteria:

1. Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
2. Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
3. Bipolar disorder as assessed by MINI International Neuropsychiatric Interview
4. Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview
5. 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
6. Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
7. Metal implants in cranium or any electrical implants
8. Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS
9. Visibly non-intact skin/rash on scalp areas at stimulation electrode sites
10. 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 it's running

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

Study contacts

• Principal investigator: Sophie Grigoriadis, MD, PhD — Sunnybrook Health Sciences Centre
• Study coordinator: Simone Vigod
• Email: simone.vigod@wchospital.ca
• Phone: 4163236400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.