Postpartum Depression Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
NOT_YET_RECRUITING
Toronto
Women's College Hospital
RECRUITING
Toronto
Contact Information
Primary
Simoe Vigod
simone.vigod@wchospital.ca
4163236400
Time Frame
Start Date: 2021-11-08
Estimated Completion Date: 2027-06
Participants
Target number of participants: 156
Treatments
Experimental: 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.
Sham_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Centre for Addiction and Mental Health, Sunnybrook Health Sciences Centre
Leads: Women's College Hospital

This content was sourced from clinicaltrials.gov