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临床试验/NCT06743633
NCT06743633尚未招募不适用

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

Chitkara University0 个研究点目标入组 1,136 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,136
主要终点
An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 6 months

β-blockers use are associated with antidepressant effect or not

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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