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WB001 with adjunctive Treatment as Usual for Postpartum Depression

N/A

Waitlist Available

Research Sponsored by Woebot Labs, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pgi-s: change from baseline to post-treatment at week 8; pgi-c: change from mid-treatment at week 4 to post-treatment at week 8

Awards & highlights

Study Summary

This trial tests if two digital tools can help reduce symptoms of postpartum depression in women.

Eligible Conditions

Postpartum Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pgi-s: change from baseline to post-treatment at week 8; pgi-c: change from mid-treatment at week 4 to post-treatment at week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pgi-s: change from baseline to post-treatment at week 8; pgi-c: change from mid-treatment at week 4 to post-treatment at week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and pgi-s: change from baseline to post-treatment at week 8; pgi-c: change from mid-treatment at week 4 to post-treatment at week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mental Depression

Secondary outcome measures

Client Satisfaction Questionnaire (CSQ-8)

Clinical Global Impressions Scale - Global Improvement (CGI-I)

Clinical Global Impressions Scale - Severity of Illness (CGI-S)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: WB001 with adjunctive Treatment as UsualExperimental Treatment1 Intervention

Participants randomized to the WB001 + TAU group will be asked to download and use the study application.

Group II: Educational Control (ED001) with adjunctive Treatment as UsualExperimental Treatment1 Intervention

Participants randomized to the ED001 + TAU group will be asked to download and use the study application.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

WB001

2020

N/A

~90

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Who is running the clinical trial?

Woebot Labs, Inc.Lead Sponsor

6 Previous Clinical Trials

772 Total Patients Enrolled

Woebot HealthLead Sponsor

13 Previous Clinical Trials

2,106 Total Patients Enrolled

2 Trials studying Postpartum Depression

83 Patients Enrolled for Postpartum Depression

Iqvia Pty LtdIndustry Sponsor

106 Previous Clinical Trials

170,001 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What eligibility criteria must a potential participant meet in order to join this research?

"This clinical trial is recruiting 210 individuals aged 22 to 45 who suffer from postpartum depression. Participants must be female, have a recent major depressive episode occurring during pregnancy or within 4 weeks following delivery, possess an Android/iOS smartphone and reliable Wifi access, and their TAU (outpatient care management) needs to have been stable for at least one month prior to the baseline visit. Furthermore, they need a HAMD-6 score between 7 - 13 which indicates mild-moderate symptoms of depression."

Answered by AI

How many participants are involved in this experiment?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical research project, which was first posted on November 16th 2022, is currently searching for participants. 210 subjects must be recruited from 1 designated location."

Answered by AI

Does this exploration include individuals aged 45 and up?

"This trial is only open to participants that are between 22 and 45 years of age. In contrast, there are 197 clinical studies for those under 18 years old and 969 trials for people 65 or older."

Answered by AI

Are there vacancies left in the experiment for prospective participants?

"According to the data found on clinicaltrials.gov, this research is currently seeking patients for participation. It was originally posted at the 16th of November 2022 and last updated two days later."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]

2022. "[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05551195.