RecruitingNot ApplicableNCT05097586

RCT of At-Home tDCS for Depression in Pregnancy

Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy


Sponsor

Women's College Hospital

Enrollment

156 participants

Start Date

Nov 8, 2021

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether at-home brain stimulation (called tDCS — a mild, non-invasive electrical current applied to the scalp) can reduce depression in pregnant women who do not want to take antidepressants. Participants use the device at home under remote supervision. **You may be eligible if...** - You are an adult (18 or older) who is between 12 and 32 weeks pregnant with a single baby - You are experiencing a moderate-to-severe major depressive episode (PHQ-9 score ≥ 10) - You have been offered antidepressants by a psychiatrist but declined to take them - You have not started any new treatment for depression in the 4 weeks before the study **You may NOT be eligible if...** - You have active alcohol or substance use disorder in the past 12 months - You have active suicidal thoughts - You have bipolar disorder, schizophrenia, or another psychotic disorder - You have metal implants in your skull or any electrical implants - You have a major unstable medical illness, pre-eclampsia, or a history of seizures - You are taking certain psychiatric medications (benzodiazepines above low dose, anticonvulsants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEactive tDCS

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

OTHERworkbook

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

DEVICEsham 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


Locations(2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

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NCT05097586


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