Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT04011592
Eligibility Criteria:
Inclusion Criteria:
* Female subjects, ages 18-45 years
* Experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery and with moderate or severe symptoms (\>12 EPDS or \>14 HAM-D).
* No or partial response to adequate doses of SSRI medications to treat PND for longer than 6 weeks.
* PND patients will be requested to maintain the stable dose of antidepressants while enrolled in the study trial.
* Patients that can speak and read the English language, are able to understand the study procedures and sign the informed consent
Exclusion Criteria:
* No current or past psychosis or severe personality disorder.
* No current substance abuse or dependence.
* No serious and imminent suicidal or homicidal risk.
* No recent or history of major and unstable medical problems that affect brain anatomy, neurochemistry, or function.
* Not diagnosed with cardiovascular disorders.
* No increased risk of laryngospasm or active upper respiratory infections.
* Not diagnosed with an intellectual disability or neurodegenerative diseases.
* Mothers that are currently breastfeeding.
* No current pregnancy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04011592
Study Brief:
Protocol Section:
NCT04011592