A headset for depression in pregnancy — science tests a Drug-Free option
NCT ID NCT05097586
First seen Jul 30, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This trial tests whether a non-invasive brain-stimulation device called transcranial direct current stimulation (tDCS) can reduce symptoms of moderate-to-severe depression in pregnant people. Participants use the device at home for 15 sessions over three weeks, while a comparison group receives a sham (inactive) device. The study aims to see if tDCS offers a safe, medication-free way to manage depression during pregnancy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a gentle brain-stimulation device called transcranial direct current stimulation (tDCS), delivering a low electrical current to the scalp
- What this could lead to
- If it works, this could offer a drug-free option for treating depression during pregnancy, when medication choices are limited.
- What could go wrong
- This is a mid-sized trial, and the sham group also receives a workbook, so the added benefit of tDCS may be small. The device is used at home, so correct use and adherence are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Women's College Hospital
RECRUITINGToronto, Ontario, M5S1B2, Canada
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