An interventional study of Psychiatric treatment with sertraline and Psychiatric treatment with escitalopram in Coronary Artery Disease, Depression and Cardiovascular Diseases, sponsored by Klinički Bolnički Centar Zagreb. Status unknown at 1 site in Croatia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Klinički Bolnički Centar Zagreb · Not applicable, Interventional, and Treatment
Cardiovascular disease increases the risk of depression and vice versa. Many cardiovascular patients are subjected to percutaneous coronary intervention (PCI). Potential biomarkers for the development, the course and the recovery of both diseases are in the focus of interest of many studies. One of the biomarkers that stands out is brain derived neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons.
The aim of the study is to detect the depression in patients undergoing PCI and to determine the impact of psychiatric treatment on the functional recovery and on the changes of BDNF.
It has been shown that cardiovascular disease increases the risk of depression and vice versa. A significant proportion of cardiovascular diseases are coronary artery disease; most of these patients are subjected to percutaneous coronary intervention (PCI). That population of patients, which is under greater risk of depression, has been passing through the health system without adequate management of psychiatric difficulties. Despite the abundance of the data regarding the concomitancy of cardiovascular disease and depression, potential biomarkers for the development, the course and the recovery of both diseases are still in the focus of interest of many studies. One of the biomarkers that stands out is brain derived neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons. Its' serum level is reduced in cardiac failure and acute coronary syndrome, and indicates a higher risk of coronary incident in angina pectoris. BDNF is also reduced in depression, but increases during a pharmacological treatment along with the clinical improvement.
Therefore the aim of the study is to detect the occurrence of depression in patients undergoing PCI and to determine the impact of psychiatric treatment on the functional recovery of those patient and the correlation with the changes of serum levels of BDNF.
This represents the objectivization of the tertiary type of prevention intervention for recovery of cardiovascular patients who are currently passing through the investigator's health system with unrecognized psychiatric comorbidity.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Klinički Bolnički Centar Zagreb is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression
Drug: Psychiatric treatment with sertraline
Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention
Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression
Drug: Psychiatric treatment with escitalopram
Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI
Also known as: Intervention I
Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of newly recognized depression in patients after PCI
Also known as: Intervention II
Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months
A 10-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe).
Time frame: baseline, six months
Change from Baseline Hamilton Rating Scale for Depression (HAM-D) at 6 months
Semi-structured interview with 17 questions, designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Time frame: baseline, six months
Change from Baseline Beck Depression Inventory (BDI) at 6 months
A 21-question multiple-choice self-report inventory, with each question having a set of four and more possible responses, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score represents the sum of the values. Higher total score indicates more severe depressive symptoms.
Time frame: baseline, six months
Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months
EQ-5D is a standardized instrument for measuring generic health status. Questionnaire has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and all dimensions are described by 3 problem levels corresponding to patient response choices. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale.
Time frame: baseline, six month
Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months
Changes in GRACE ACS Risk Model of cardiovascular patients six months after PCI
Time frame: baseline, six months
Change from Baseline Duke Activity Status Index (DASI) at 6 months
The Duke Activity Status Index (DASI) is an a 12-item questionnaire assessment tool used to evaluate the functional capacity of patients with cardiovascular disease. Each item has a specific weight based on the metabolic cost. The final score ranges between zero and 58.2 points. The higher the score indicates better functional capacity.
Time frame: baseline, six months
Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months
SAQ is a 19-item instrument that measures patient-reported symptoms, function and quality of life for patients with coronary artery disease. The answers patients give to the SAQ's questions are used to calculate scores in five scales: anginal stability, anginal frequency, physical limitation, treatment satisfaction and quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better functioning.
Time frame: baseline, six months
Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months
Changes in the serum levels of BDNF six months after PCI in cardiovascular patients without and cardiovascular patients with depressive symptoms
Time frame: baseline, six months
Plan to share: No
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Klinički Bolnički Centar Zagreb