NCT05097586Recruiting
RCT of At-Home tDCS for Depression in Pregnancy
Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 1 Oct 2021
- Start date
- 8 Nov 2021
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Women's College Hospital
- Diseases
- Depression
- NCT number
- NCT05097586
What you commit to
- Study type: Interventional
- Planned participants: 156
- From 8 Nov 2021 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
- Metal implants in cranium or any electrical implants
Other illness
- 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
Other
- Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Women's College Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.