CClinicalTrials.gg
Not yet recruitingNCT06743633Updated Dec 20, 2024

Association of Beta Blocker Use with Depressive Outcomes

An observational study in Depression - Major Depressive Disorder, sponsored by Chitkara University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Chitkara University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,136
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Depression - Major Depressive Disorder

Keywords

  • Beta-blockers
  • Depression
  • Prevalence
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 1,136 is above the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Chitkara University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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)

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,136 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06743633
Lead sponsor
Chitkara University
Responsible party
Sponsor
First posted
Dec 20, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Apr 30, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Dec 20, 2024

Study contacts

Ravi Kant, PhD
Contact
ravi.kant143@chitkara.edu.in
+918130786072
Pritika Bhatia, M pharmacy
Contact
pritikabhatia123@gmail.com
+917876227735

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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