Clinical trial NCT06743633: Association of Beta Blocker Use with Depressive Outcomes
Official title: An Observational Study to Explore the Association Between Beta Blocker Use and Depressive Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Depression - Major Depressive Disorder
Keywords: Beta-blockers
Depression
Prevalence
Lead sponsor: Chitkara University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 1136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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)

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

Detailed description: 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.

Eligibility criteria: For Prospective Study:-

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.

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:-

Inclusion criteria:

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

Primary outcomes:
measure: An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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