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Device

At-Home tDCS for Depression in Pregnancy

N/A

Recruiting

Led By Daniel Blumberger, MD, MSc

Research Sponsored by Women's College Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Summary

This trial will compare transcranial direct current stimulation (tDCS) against a sham condition to see if it is more effective at reducing symptoms of depression in pregnant people with moderate to severe depression. 156 participants will be enrolled at various data collection points throughout pregnancy and up to one year postpartum.

Who is the study for?

This trial is for pregnant individuals over 18 with moderate to severe depression, between 12-32 weeks into their pregnancy. They must have declined antidepressants and not started any new treatments for depression in the last month. Exclusions include active suicidality, bipolar disorder, major pregnancy complications, metal or electrical implants in the head, certain medication use that affects tDCS treatment, non-intact scalp skin, inability to consent in English or complete a workbook in French/English.

What is being tested?

The study tests if transcranial direct current stimulation (tDCS) can reduce depression symptoms better than a sham (fake) treatment during pregnancy. Participants are randomly assigned to receive either active tDCS or sham alongside a workbook therapy. The effects will be monitored throughout pregnancy and up until one year postpartum.

What are the potential side effects?

Possible side effects of tDCS may include discomfort at the electrode sites on the scalp like itching or tingling sensations during application; headache; fatigue; nausea; and insomnia. These side effects are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently experiencing a moderate to severe depressive episode without psychosis.

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I am pregnant with one baby and between 12 to 32 weeks along.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not use benzodiazepines or anticonvulsants regularly, except for low-dose lorazepam.

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I have visible skin issues or rashes where electrodes might be placed on my scalp.

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I do not have any severe or life-threatening illnesses, including advanced cancer, severe pregnancy complications, or neurological conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depressive symptoms post treatment

Secondary study objectives

Child Development

Depressive symptoms

Dyadic Relationship

+11 more

Other study objectives

Concurrent Health Service Use

Integrity of Treatment Blindness Questionnaire

Stanford Expectancy Scale

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: active tDCSExperimental Treatment2 Interventions

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 II: controlPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

active tDCS

2018

N/A

~790

0 / 6Eligibility criteria met