Major Depression study: Active tDCS
Official title RCT of At-Home tDCS for Depression in Pregnancy
ClinicalTrials.gov ID: NCT05097586
What this study is testing
- What it's testing
- This study is testing whether tDCS (a gentle electric current applied to the scalp) can reduce depression symptoms in pregnant people more than a pretend treatment.
- Who it's for
- You may be able to join if you are pregnant, have moderate to severe depression, and are between 12 and 36 weeks pregnant.
- What's involved
- You will use a small device at home that sends a mild electric current to your scalp. You will also have check‑ins and give feedback on how you feel.
- Time commitment
- The study lasts about 12 months, with visits at the start, after treatment, every 4 weeks during pregnancy, and at 4, 12, 26, and 52 weeks after birth.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
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...
- Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment...
- No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting...
You likely can't 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...
- Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.