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WITHDRAWN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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Internal company decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-06-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression (HAM-D)', 'timeFrame': 'Change from Baseline to Week 4; Change from Baseline to Week 8', 'description': 'Clinician-rated measure of depression. The HAM-D6 is a subset of the HAM-D17 that assesses the 6 core items associated with major depression. Scores range from 0-22, where higher scores indicate greater depression severity.'}], 'secondaryOutcomes': [{'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', 'description': 'Measure of depression. A 9-item self-report questionnaire where total scores range from 0 to 27, with higher scores indicating greater levels of depression.'}, {'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', 'description': 'Measure of postpartum depression. A 10-item self-report questionnaire that assesses depression criteria and yields a total score from 0 to 30 where higher scores denote greater depression.'}, {'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', 'description': 'Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety.'}, {'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', 'description': 'Measure of mother-infant bond. An 8-item self-report questionnaire, where total scores range from 0 to 24, with lower scores indicating good bonding.'}, {'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', 'description': 'Measure of disease severity. A single-item scale asking respondents to rate the severity of their disease.'}, {'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', 'description': 'Measure of risk for suicide. A clinician-administered assessment that measures four constructs: the severity of ideation, the intensity of ideation, behavior, and lethality. The C-SSRS consists of 10 categories with binary responses (Yes or No) to indicate the presence or absence of the behavior with a numerical score outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Postpartum Depression'], 'conditions': ['Postpartum Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/NCT05551195', 'label': '\\[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression\\]'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must have prior enrollment in the WB001-001 trial and completion of Week 8/EOT\n2. Must be willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1\\. Documented AE or SAE at WB001-001 Week 8 related to participant safety, by Investigator judgement'}, 'identificationModule': {'nctId': 'NCT05693792', 'briefTitle': 'A Six-Month Prospective Follow-Up Study of WB001', 'organization': {'class': 'INDUSTRY', 'fullName': 'Woebot Health'}, 'officialTitle': 'A Six-Month Prospective Follow-Up Study of WB001 in Mild to Moderate Postpartum Depression', 'orgStudyIdInfo': {'id': 'WB001-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Follow-up Group', 'description': 'Participants randomized to {WB001+TAU} and {ED001+TAU} in the parent study (WB001-001) will be assessed for 6 months following treatment completion.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'No treatment regimen will be deployed in this follow-up study.', 'armGroupLabels': ['Follow-up Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Woebot Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}