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 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT05551195
Eligibility Criteria:
Inclusion Criteria:
1. Must have primary residence in the United States
2. Must be ≤ 92 days postpartum
3. Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
4. Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
5. Participants must have current mild-moderate depression as measured by the HAMD-6 score \>7 and \<13 at screening
6. Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof
7. TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit
Exclusion Criteria:
1. Gestation less than 28 weeks
2. HAMD-6 score ≤7 or ≥13 (severe depression) at screening
3. Currently pregnant or plans to become pregnant within the next 8 weeks
4. History of drug and/or alcohol use disorder within the past 12 months
5. Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
6. Current or lifetime psychosis
7. Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation
8. History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device
9. History of treatment-resistant depression (TRD)
10. Fetal demise within the past 18 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
22 Years
Maximum Age:
45 Years
Study:
NCT05551195
Study Brief:
Protocol Section:
NCT05551195