Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-10 @ 8:47 AM
Study NCT ID:
NCT05551195
Status:
TERMINATED
Last Update Posted:
2025-02-24
First Post:
2022-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
Sponsor:
Woebot Health
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women With Mild to Moderate Postpartum Depression
Status:
TERMINATED
Status Verified Date:
2025-01
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 evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
Detailed Description:
This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).
Study Oversight
Has Oversight DMC:
True
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?: