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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT03228394
Eligibility Criteria:
Inclusion Criteria:
* Participant experienced a Major Depressive Episode, which started between the start of the third trimester and 4 weeks following delivery. The Major Depressive Episode must be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0 interview
* Participant gave birth in the last 6 months
* Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥ 26 at screening
* Participant must agree to stop breastfeeding from start of study treatment or must agree to temporarily cease giving breast milk to her infant(s)
Exclusion Criteria:
* Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features
* History of suicide attempt within the past 3 years
* Active suicidal ideation
* History of bipolar I disorder
* History of seizure disorder
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03228394
Study Brief:
Protocol Section:
NCT03228394