Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 8:55 PM
Study NCT ID:
NCT05016050
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-17', 'mcpReleaseN': 6, 'releaseDate': '2024-11-22'}], 'estimatedResultsFirstSubmitDate': '2024-11-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 367}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'baseline to end of treatment (8-10 weeks)', 'description': 'A 9-item self-report measure to assess symptoms of depression'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'baseline to end of treatment (8-10 weeks)', 'description': 'A 7-item self-report measure to assess symptoms of anxiety'}], 'secondaryOutcomes': [{'measure': 'PHQ-9', 'timeFrame': 'Through study completion, average of 14 months', 'description': 'A 9-item self-report measure to assess symptoms of depression'}, {'measure': 'GAD-7', 'timeFrame': 'Through study completion, average of 14 months', 'description': 'A 7-item self-report measure to assess symptoms of anxiety'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['depression', 'anxiety'], 'conditions': ['Major Depressive Disorder', 'Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'Participants with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) will use a prescribed digital therapeutic for 8-10 weeks, and will complete depression and anxiety measures during this time. After the treatment period, participants will be followed monthly for 12 months.', 'detailedDescription': 'This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults 22 years or older at the time of screening\n2. Meets DSM-5 diagnostic criteria for Major Depressive Disorder or Generalized Anxiety Disorder\n3. Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration\n4. Currently residing in the United States\n\nKey Exclusion Criteria:\n\n1. Risk of suicide or has attempted suicide within 24 months of the screening visit\n2. Moderate to severe substance use disorder\n3. Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, or Borderline Personality Disorder\n4. Currently pregnant or planning to become pregnant during the treatment period\n\nNote: Other protocol-defined inclusion/exclusion criteria applied.'}, 'identificationModule': {'nctId': 'NCT05016050', 'briefTitle': 'Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Happify Inc.'}, 'officialTitle': 'A Real-World Evidence, Single-Arm, Open-Label Study Evaluating the Safety and Efficacy of HPDT-DA-013 Digital Therapeutic in the Treatment of Major Depressive Disorder(MDD)and Generalized Anxiety Disorder(GAD)', 'orgStudyIdInfo': {'id': 'HPY-HPDT-DA-013-RWE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital therapeutic', 'description': 'Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks.', 'interventionNames': ['Device: HPDT-DA-013']}], 'interventions': [{'name': 'HPDT-DA-013', 'type': 'DEVICE', 'description': 'Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).', 'armGroupLabels': ['Digital therapeutic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Happify Health (Remote)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Roger Vilardaga, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Happify Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}