RCT of At-Home tDCS for Depression in Pregnancy

NCT05097586 | Recruiting DMC

• 1 other identifier: CTO Project ID: 3263
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Major Depression; Pregnancy; Postpartum Depression

Keywords

Pregnancy; Depression; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms post 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

  End of Week 3 of treatment

Secondary Outcomes (14)

• Remission of depression

  4 weeks postpartum

• Depressive symptoms

  End of Week 1, and Week 2 of treatment, q4 weeks during pregnancy, and 4-, 12-, 26- and 52-weeks postpartum

• Self-reported depressive symptoms

  End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)

• Self-reported anxiety symptoms

  End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)

• Maternal Quality of Life (QoL)

  End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)

Other Outcomes (4)

• Concurrent Health Service Use

  End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)

• Tolerability of Intervention

  End of Week 1, Week 2 and Week 3 of treatment

• Stanford Expectancy Scale

  Baseline

Study Arms (2)

active tDCS

EXPERIMENTAL

2mA of direct current delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.

Device: active tDCS; Other: workbook

control

SHAM COMPARATOR

Sham stimulation where the current is turned off after 30 seconds in a slow ramp down, delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.

Other: workbook; Device: sham tDCS

Interventions

active tDCS DEVICE

2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks

active tDCS

workbook OTHER

Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state

active tDCS; control

sham tDCS DEVICE

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

control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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

Sponsors & Collaborators

• Women's College Hospital: lead
• Centre for Addiction and Mental Health: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

NOT YET RECRUITING

Women's College Hospital

Toronto, Ontario, M5S1B2, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Study Officials

• Sophie Grigoriadis, MD, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Daniel Blumberger, MD, MSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Simone Vigod, MD, MSc

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simoe Vigod

CONTACT

4163236400; simone.vigod@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Psychiatry, Senior Scientist

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 28, 2021
• Study Start: November 8, 2021
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CA (2)