Association of Beta Blocker Use with Depressive Outcomes

NCT06743633 | Not Yet Recruiting

• 1 other identifier: 2350981060
• Study Type: observational
• Target: 1,136
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression - Major Depressive Disorder

Keywords

Beta-blockers; Depression; Prevalence

Outcome Measures

Primary Outcomes (1)

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

  β-blockers use are associated with antidepressant effect or not

  6 months

Study Arms (4)

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

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

Prospective study: Cardiovascular disease patients without β-blockers therapy

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

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.

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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: 453 participants from psychiatric department (two subgroups = 226 with β-blockers and other 226 without β-blockers)

You may qualify if:

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

You may not qualify if:

• \. 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:-
• Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
• Participants with cardiovascular co-morbidity.
• Participants aged from ≥18 years.
• \. Depression with other psychiatric illness for e.g., schizophrenia, cognitive impairment and without any cardiac comorbidity.

Sponsors & Collaborators

• Chitkara University: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Ravi Kant, PhD

CONTACT

+918130786072; ravi.kant143@chitkara.edu.in

Pritika Bhatia, M pharmacy

CONTACT

+917876227735; pritikabhatia123@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 31, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share