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NCT Number: NCT06743633

Association of Beta Blocker Use with Depressive Outcomes

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For Prospective Study:-

Inclusion criteria

  • 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.

Exclusion criteria

  • 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:-

Inclusion criteria

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

Exclusion criteria

  • Depression with other psychiatric illness for e.g., schizophrenia, cognitive impairment and without any cardiac comorbidity.

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

    β-blockers use are associated with antidepressant effect or not

Study contacts

Contact information is provided by the study sponsor or research team.

Pritika Bhatia, M pharmacy

CONTACT

[email protected]

+917876227735

Ravi Kant, PhD

CONTACT

[email protected]

+918130786072

Sponsors and collaborators

Lead sponsor

Chitkara University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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