Association of Beta Blocker Use with Depressive Outcomes

NCT ID: NCT06743633

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-05-31

Brief Summary

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An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes

Detailed Description

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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.

In the Retrospective study, clinically diagnosed depression patients with cardiovascular co morbidity will be identified from the psychiatric department.

Study 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.

Retrospective: 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.

Conditions

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Depression - Major Depressive Disorder

Keywords

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Beta-blockers Depression Prevalence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Prospective study: Cardiovascular disease patients on β-blockers therapy atleast from last 1 year

Evaluation of depression status using ICD 10, HADS, PHQ-9

No interventions assigned to this group

Prospective study: Cardiovascular disease patients without β-blockers therapy

Evaluation of depression status using ICD 10, HADS, PHQ-9.

No interventions assigned to this group

Retrospective study: Clinically diagnosed Depression patients + Cardiovascular comorbidities

To determine the prevalence of patients on β-blocker use among clinically diagnosed depression patients with cardiovascular comorbidities by reviewing their medical records.

No interventions assigned to this group

Retrospective study:Clinically diagnosed Depression + Cardiovascular comorbidities without β-blocker

To determine the prevalence of patients without β-blocker use among clinically diagnosed depression patients with cardiovascular comorbidities by reviewing their medical records.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Participants aged from ≥18 years at the time of consent.
2. Participants on β-blockers for at least 1 year.
3. No significant cognitive impairment.
4. Participants who are willing to participate.
5. To be able to understand and answer the self-assessment questionnaires.


1. Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
2. Participants with cardiovascular co-morbidity.
3. Participants aged from ≥18 years.

Exclusion Criteria

1\. 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.

For Retrospective Study:-


1\. Depression with other psychiatric illness for e.g., schizophrenia, cognitive impairment and without any cardiac comorbidity.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chitkara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ravi Kant, PhD

Role: CONTACT

Phone: +918130786072

Email: [email protected]

Pritika Bhatia, M pharmacy

Role: CONTACT

Phone: +917876227735

Email: [email protected]

Other Identifiers

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2350981060

Identifier Type: -

Identifier Source: org_study_id