RCT of At-Home tDCS for Depression in Pregnancy

NCT ID: NCT05097586

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2027-06-30

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

Detailed Description

Transcranial direct current stimulation (tDCS) is a brain stimulation technique for the treatment of depression that has great potential for filling the gap in treatment options for moderate and severe depression in pregnancy. Participants are randomized 1:1 to active tDCS treatment or sham control. After at least one in-person training session with the research team, participants take the tDCS device home and self-administer 30-minute treatments 5 times per week, for 3 weeks, for a total of 15 sessions. Rater-administered and self-report outcomes are collected weekly during the 3-week active treatment phase, every 4 weeks during pregnancy, and at 4-, 12-, 26- and 52-weeks postpartum. A mixed methods process evaluation is embedded into the trial.

Conditions

Major Depression; Pregnancy; Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active tDCS

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.

Group Type: EXPERIMENTAL

active tDCS

Intervention Type: DEVICE

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

workbook

Intervention Type: OTHER

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

control

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.

Group Type: SHAM_COMPARATOR

workbook

Intervention Type: OTHER

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

sham tDCS

Intervention Type: 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

Interventions

active tDCS

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

Intervention Type: DEVICE

workbook

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

Intervention Type: OTHER

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Simone Vigod

Principal Investigator, Professor of Psychiatry, Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophie Grigoriadis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Daniel Blumberger, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Simone Vigod, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Women's College Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Simoe Vigod

Role: CONTACT

simone.vigod@wchospital.ca

4163236400 ext. 4080

Facility Contacts

Sophie Grigoriadis, MD

Role: primary

sophie.grigoriadis@sunnybrook.ca

416-480-5677

Simone Vigod, MD

Role: primary

simone.vigod@wchospital.ca

4163236400 ext. 4080

Other Identifiers

CTO Project ID: 3263

Identifier Type: -

Identifier Source: org_study_id