RCT of At-Home tDCS for Depression in Pregnancy

Launched by WOMEN'S COLLEGE HOSPITAL · Oct 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called transcranial direct current stimulation (tDCS) can help reduce depression symptoms in pregnant women who are experiencing moderate to severe depression. The trial will involve 156 participants and will compare the actual treatment to a placebo, which is a fake treatment that looks the same but doesn’t have any active effect. If you are a woman aged 18 or older, in your second or third trimester of a single pregnancy, and have been diagnosed with major depression but have chosen not to take antidepressant medications, you may be eligible to participate.

Participants in the study will receive the tDCS treatment at home and will be monitored over time. They will have assessments at the start of the trial, right after treatment, and then every four weeks during pregnancy, as well as at various points after giving birth. It's important to know that certain conditions, such as alcohol or substance use disorders, active suicidality, and specific medical issues, would exclude someone from participating. This trial aims to provide valuable information on how effective tDCS can be for treating depression during pregnancy, which could help improve care for future patients.

Gender

FEMALE

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