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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02942004
Eligibility Criteria:
Key Inclusion Criteria:
* Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion
* Participants had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
* Participant had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)
* Participant was ≤6 months postpartum at screening
* Participant was amenable to IV therapy
Key Exclusion Criteria:
* Active psychosis
* Attempted suicide associated with index case of postpartum depression
* Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.
Note: Other protocol-defined inclusion/exclusion criteria applied.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02942004
Study Brief:
Protocol Section:
NCT02942004