Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT05693792
Status:
WITHDRAWN
Last Update Posted:
2023-05-06
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Six-Month Prospective Follow-Up Study of WB001
Sponsor:
Woebot Health
Organization:
Study Overview
Official Title:
A Six-Month Prospective Follow-Up Study of WB001 in Mild to Moderate Postpartum Depression
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Internal company decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: