Clinical trial NCT05693792: A Six-Month Prospective Follow-Up Study of WB001
Official title: A Six-Month Prospective Follow-Up Study of WB001 in Mild to Moderate Postpartum Depression
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Postpartum Depression
Keywords: Postpartum Depression
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the current study 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Must have prior enrollment in the WB001-001 trial and completion of Week 8/EOT
2. Must be willing and able to comply with all study procedures

Exclusion Criteria:

1. Documented AE or SAE at WB001-001 Week 8 related to participant safety, by Investigator judgement

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Change from Baseline to Week 4; Change from Baseline to Week 8
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24
measure: Edinburgh Postpartum Depression Scale (EPDS)
timeFrame: Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24
measure: Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24
measure: Mother-to-Infant Bonding Scale (MIBS)
timeFrame: Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24
measure: Patient Global Impression scale (PGI)
timeFrame: Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24
Other outcomes:
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