NCT05693792

A Six-Month Prospective Follow-Up Study of WB001

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Woebot Health · Industry
• Sex: Female
• Age: 22 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
OTHER	Observational	No treatment regimen will be deployed in this follow-up study.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-06-08
• Completion: 2024-06-08
• First posted: 2023-01-23
• Last updated: 2023-05-06

Regulatory

• FDA-regulated device study