A Six-Month Prospective Follow-Up Study of WB001

Study Overview
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Brief Summary
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This study is a 6-month follow-up study to WB001-001 conducted to assess and evaluate the durability of the effect of {WB001+TAU} beyond the 8-week treatment period.

Detailed Description
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This study is a 6-month prospective, observational follow-up study to the WB001-001 trial. Participants will be a convenience sample of those enrolled in the WB001-001 parent trial who consent to participate in a follow-up study at baseline for WB001-001. After completion of WB001-001's EOT assessment, those consenting to participate in the current study will be screened to confirm eligibility. Eligible participants will complete six assessment batteries (patient-reported outcomes [PROs]) on a monthly basis for a 6-month observation period.

Official Title
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A Six-Month Prospective Follow-Up Study of WB001 in Mild to Moderate Postpartum Depression

Conditions
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Postpartum Depression

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have prior enrollment in the WB001-001 trial and completion of Week 8/EOT Must be willing and able to comply with all study procedures Exclusion Criteria: 1. Documented AE or SAE at WB001-001 Week 8 related to participant safety, by Investigator judgement

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Follow-up Group<br>Participants randomized to {WB001+TAU} and {ED001+TAU} in the parent study (WB001-001) will be assessed for 6 months following treatment completion. | Other: Observational<br>* No treatment regimen will be deployed in this follow-up study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) | Clinician-rated measure of depression. The HAM-D6 is a subset of the HAM-D17 that assesses the 6 core items associated with major depression. Scores range from 0-22, where higher scores indicate greater depression severity. | Change from Baseline to Week 4; Change from Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | Measure of depression. A 9-item self-report questionnaire where total scores range from 0 to 27, with higher scores indicating greater levels of depression. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 | 
| Edinburgh Postpartum Depression Scale (EPDS) | Measure of postpartum depression. A 10-item self-report questionnaire that assesses depression criteria and yields a total score from 0 to 30 where higher scores denote greater depression. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 | 
| Generalized Anxiety Disorder Questionnaire (GAD-7) | Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 | 
| Mother-to-Infant Bonding Scale (MIBS) | Measure of mother-infant bond. An 8-item self-report questionnaire, where total scores range from 0 to 24, with lower scores indicating good bonding. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 | 
| Patient Global Impression scale (PGI) | Measure of disease severity. A single-item scale asking respondents to rate the severity of their disease. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 | 
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Measure of risk for suicide. A clinician-administered assessment that measures four constructs: the severity of ideation, the intensity of ideation, behavior, and lethality. The C-SSRS consists of 10 categories with binary responses (Yes or No) to indicate the presence or absence of the behavior with a numerical score outcome. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Depression