Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 3:29 PM
Study NCT ID:
NCT06743633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Beta Blocker Use with Depressive Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes', 'timeFrame': '6 months', 'description': 'β-blockers use are associated with antidepressant effect or not'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Beta-blockers', 'Depression', 'Prevalence'], 'conditions': ['Depression - Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes', 'detailedDescription': 'Study design- This is a Prospective, Retrospective, Cross-sectional observational study. In prospective study, cardiovascular patients will be divided into two groups: those taking β-blockers and those not taking β-blockers. A questionnaire-based study will be conducted to assess the depression status of both groups. The study will include Depression Inventory (MDI) (lCD-10), Hamilton Rating Scale for Depression (HDRS) and Patient health questionnaire-9 (PHQ-9) for prospective study.\n\nIn the Retrospective study, clinically diagnosed depression patients with cardiovascular co morbidity will be identified from the psychiatric department.\n\nStudy population- Total number of patients to be included in both prospective and retrospective study: 1136 Prospective: 684 participants from cardiology department (two subgroups = 342 with β-blockers and other 342 without β-blockers) Retrospective: 452 participants from psychiatric department (two subgroups = 226 with β-blockers and other 226 without β-blockers) Planned time period for the study: Jan 2025 to May 2025 Procedure- Prospective: A prospective study, a total of 684 cardiovascular participants will be recruited from the Cardiology department. Participants will be divided into two groups: participants who are currently on β-blockers from at least 1 year and those who are not on β-blockers. Then a Depression Inventory (MDI) (lCD-10), Hamilton Rating Scale for Depression (HDRS) and PHQ-9 (Patient health questionnaire-9) depression questionnaire will be run on both to assess depression levels. Data collected from both groups will be compared to evaluate differences in depression status.\n\nRetrospective: A retrospective study will be conducted involving 452 patients diagnosed with depression and atleast one cardiovascular co morbidity from the psychiatry department. Patients will be classified into two groups: those who were prescribed with β-blockers and those who were not. Medical records of these patients will be obtained from their respective Staff. The primary objective is to determine the prevalence of β-blocker use among depressed patients with cardiovascular conditions by reviewing their medical histories.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Total number of patients to be included in both prospective and retrospective study: 1136 Prospective: 684 participants from cardiology department (two subgroups = 342 with β-blockers and other 342 without β-blockers) Retrospective: 453 participants from psychiatric department (two subgroups = 226 with β-blockers and other 226 without β-blockers)', 'healthyVolunteers': False, 'eligibilityCriteria': 'For Prospective Study:-\n\nInclusion Criteria:\n\n1. Participants aged from ≥18 years at the time of consent.\n2. Participants on β-blockers for at least 1 year.\n3. No significant cognitive impairment.\n4. Participants who are willing to participate.\n5. To be able to understand and answer the self-assessment questionnaires.\n\nExclusion Criteria:\n\n1\\. Having severe sensory and physical limitations, severe disconnection from the environment, or presence of severe neuropsychiatric symptoms that make it impossible to administer the assessment.\n\nFor Retrospective Study:-\n\nInclusion criteria:\n\n1. Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.\n2. Participants with cardiovascular co-morbidity.\n3. Participants aged from ≥18 years.\n\nExclusion criteria:\n\n1\\. Depression with other psychiatric illness for e.g., schizophrenia, cognitive impairment and without any cardiac comorbidity.'}, 'identificationModule': {'nctId': 'NCT06743633', 'briefTitle': 'Association of Beta Blocker Use with Depressive Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Chitkara University'}, 'officialTitle': 'An Observational Study to Explore the Association Between Beta Blocker Use and Depressive Outcomes', 'orgStudyIdInfo': {'id': '2350981060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective study: Cardiovascular disease patients on β-blockers therapy atleast from last 1 year', 'description': 'Evaluation of depression status using ICD 10, HADS, PHQ-9'}, {'label': 'Prospective study: Cardiovascular disease patients without β-blockers therapy', 'description': 'Evaluation of depression status using ICD 10, HADS, PHQ-9.'}, {'label': 'Retrospective study: Clinically diagnosed Depression patients + Cardiovascular comorbidities', 'description': 'To determine the prevalence of patients on β-blocker use among clinically diagnosed depression patients with cardiovascular comorbidities by reviewing their medical records.'}, {'label': 'Retrospective study:Clinically diagnosed Depression + Cardiovascular comorbidities without β-blocker', 'description': 'To determine the prevalence of patients without β-blocker use among clinically diagnosed depression patients with cardiovascular comorbidities by reviewing their medical records.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ravi Kant, PhD', 'role': 'CONTACT', 'email': 'ravi.kant143@chitkara.edu.in', 'phone': '+918130786072'}, {'name': 'Pritika Bhatia, M pharmacy', 'role': 'CONTACT', 'email': 'pritikabhatia123@gmail.com', 'phone': '+917876227735'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chitkara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}