At-home brain stimulation for depression during pregnancy
Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy
This study is testing if a type of at-home brain stimulation can help pregnant people with moderate to severe depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05097586 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are pregnant with a singleton pregnancy and experiencing moderate to severe major depression.
Not a fit: Patients with active substance use disorders, suicidality, or severe psychiatric conditions such as bipolar disorder or schizophrenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-pharmacological option for managing depression in pregnant individuals, potentially improving maternal and fetal health outcomes.
How similar studies have performed: Previous studies have shown promise for tDCS in treating depression, but this specific application in pregnant individuals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario and 1 other locations
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Sophie Grigoriadis, MD, PhD — Sunnybrook Health Sciences Centre
- Study coordinator: Simoe Vigod
- Email: simone.vigod@wchospital.ca
- Phone: 4163236400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.