RCT of At-Home tDCS for Depression in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen's College Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- active tDCS
- workbook
- sham tDCS
Treatment groups
156 Participants
are divided into 2 treatment groupsLocations
2Sunnybrook Health Sciences CentreM4N 3M5, TorontoOntario, Canada
Women's College HospitalM5S1B2, TorontoOntario, Canada
Sponsors and collaborators
Women's College Hospital
Lead sponsor
Centre for Addiction and Mental Health
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
Source ClinicalTrials.gov