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

NCT05551195 | Terminated Results DMC FDA Device

• 1 other identifier: WB001-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 8

Brief Summary

This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.

Conditions

Postpartum Depression

Keywords

Postpartum Depression; PPD; Postpartum Depression Treatment; PPD Treatment; Smartphone application; Digital therapeutic

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression (HAM-D)

  Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression.

  Change from Baseline to Post-treatment at Week 8

Secondary Outcomes (8)

• Edinburgh Postpartum Depression Scale (EPDS)

  Change Baseline to Post-treatment at Week 8

• Patient Health Questionnaire (PHQ-9)

  Change Baseline to Post-treatment at Week 8

• Generalized Anxiety Disorder Questionnaire (GAD-7)

  Change from Baseline to Post-treatment at Week 8

• Mother-to-Infant Bonding Scale (MIBS)

  Change from Baseline to Post-treatment at Week 8

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

  Change Baseline to Post-treatment at Week 8

Study Arms (2)

WB001 with adjunctive Treatment as Usual

OTHER

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

Device: WB001

Educational Control (ED001) with adjunctive Treatment as Usual

OTHER

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

Device: ED001

Interventions

WB001 DEVICE

WB001 is a digital therapeutic for postpartum depression.

WB001 with adjunctive Treatment as Usual

ED001 DEVICE

ED001 is a digital therapeutic for postpartum depression.

Educational Control (ED001) with adjunctive Treatment as Usual

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must have primary residence in the United States
• Must be ≤ 92 days postpartum
• Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
• Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
• Participants must have current mild-moderate depression as measured by the HAMD-6 score \>7 and \<13 at screening
• Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof
• TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit

You may not qualify if:

• Gestation less than 28 weeks
• HAMD-6 score ≤7 or ≥13 (severe depression) at screening
• Currently pregnant or plans to become pregnant within the next 8 weeks
• History of drug and/or alcohol use disorder within the past 12 months
• Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
• Current or lifetime psychosis
• Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation
• History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device
• History of treatment-resistant depression (TRD)
• Fetal demise within the past 18 months

Sponsors & Collaborators

• Woebot Health: lead
• Iqvia Pty Ltd: collaborator

Study Sites (8)

Woebot Investigational Site

Lafayette, California, 94549, United States

Location

Woebot Investigational Site

Santa Ana, California, 92704, United States

Location

Woebot Investigational Site

DeLand, Florida, 32720, United States

Location

Woebot Investigational Site

Miami Lakes, Florida, 33016, United States

Location

Woebot Investigational Site

Seminole, Florida, 33777, United States

Location

Woebot Investigational Site

Decatur, Georgia, 30033, United States

Location

Woebot Investigational Site

Glen Oaks, New York, 11004, United States

Location

Woebot Investigational Site

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Kate Martin
• Organization: Woebot Health

kate@woebothealth.com

(415) 209-5642

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: November 16, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-01

Locations

US (8)