Depression - Major Depressive DisorderNCT06743633
Association of Beta Blocker Use with Depressive Outcomes
An observational study of Depression - Major Depressive Disorder, run by Chitkara University.
Trial summary
An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- How many people
- 1,136 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
- Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
- Participants with cardiovascular co-morbidity.
- Participants aged from ≥18 years.
Who cannot join
- 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:-
- 1. Depression with other psychiatric illness for e.g., schizophrenia, cognitive impairment and without any cardiac comorbidity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Observational Study to Explore the Association Between Beta Blocker Use and Depressive Outcomes
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.
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Beta-blockers, Depression, Prevalence
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes
β-blockers use are associated with antidepressant effect or not
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chitkara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743633
- Sponsor's protocol ID
- 2350981060
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Explore the Association Between Beta Blocker Use and Depressive Outcomes
- ClinicalTrials.gov ID
- NCT06743633
- Acronym / sponsor ID
- 2350981060
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Beta-blockers, Depression, Prevalence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,136 participants (estimated)
- Lead sponsor
- Chitkara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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:-
- 1. Depression with other psychiatric illness for e.g., schizophrenia, cognitive impairment and without any cardiac comorbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder, run by Chitkara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ravi Kant, PhD (+918130786072, ravi.kant143@chitkara.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.