active tDCS: 2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks
workbook: Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state
sham tDCS: Sham stimulation in which the current turns off after 30 seconds in a slow ramp down that mirrors sensory adaptation in ongoing stimulation, delivered in 15 sessions lasting 30 minutes each over 3 weeks
Study 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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Depressive symptoms post treatment — End of Week 3 of treatment Depressive symptoms are measured with the 10-item rater-administered Montgomery Asberg Depression Rating Scale (MADRS).The MADRS is a standard rater-administered measure with good reliability and validity in clinical populations; interviewers can achieve and maintain high levels of inter-rater reliability. Nine items are based upon patient report and one on rater observation. Items are rated on a 0-6 continuum (0=no abnormality, 6=severe; score range 0-60). A MADRS score of \<11 indicates remission. With 80% power, and a type 1 error rate of 0.05 we would require a sample size of 104 (52/group) to detect a statistically significant difference between tDCS and Sham on the primary outcome.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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