RCT of At-Home tDCS for Depression in Pregnancy (NCT05097586) | Clinical Trial Compass
RecruitingNot Applicable
RCT of At-Home tDCS for Depression in Pregnancy
Canada156 participantsStarted 2021-11-08
Plain-language summary
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 participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses at-home brain stimulation (tDCS) for depression during pregnancy — since it's not testing a drug, what does it actually involve day-to-day, and is it safe to use while I'm pregnant?
2Because this trial doesn't have a traditional phase label, what does that mean for how much is already known about tDCS safety for pregnant people specifically, and are there any risks to the baby I should understand before considering it?
3The study is measuring depressive symptoms after treatment — would you be able to monitor my mental health closely throughout, and what would happen if my depression got worse while I was participating?
4Since this is an at-home trial, how would I actually be supervised or supported if I had questions or problems with the device while managing everything else that comes with pregnancy?
5Before I think about this trial, should I consider standard treatments for depression in pregnancy first — like therapy or medication — and how does this compare to what's already available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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