The Recovery of Cardiovascular Patients With Depression

NCT03841474 | Unknown

• 1 other identifier: KBC Zagreb CoroDep
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Depression; Cardiovascular Diseases

Keywords

Brain derived neurotrophic factor; BDNF; Psychosocial indicators; Depression; Cardiovascular disease

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  baseline, six months

Secondary Outcomes (5)

• Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months

  baseline, six month

• Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months

  baseline, six months

• Change from Baseline Duke Activity Status Index (DASI) at 6 months

  baseline, six months

• Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months

  baseline, six months

• Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months

  baseline, six months

Study Arms (3)

Intervention I

EXPERIMENTAL

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

Control

NO INTERVENTION

Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention

Intervention II

EXPERIMENTAL

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

Interventions

Psychiatric treatment with sertraline DRUG

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

Intervention I

Psychiatric treatment with escitalopram DRUG

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

Intervention II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients on day of percutaneous coronary intervention due to angina pectoris or myocardial infarction
• without antidepressant drugs or major tranquilizers more than one year

You may not qualify if:

• symptoms of myocardial infarction lasting more than 12 hours
• left ventricle ejection function (LVEF) less than 40%
• earlier presence of cardiomyopathy
• acute infection

Sponsors & Collaborators

• Klinički Bolnički Centar Zagreb: lead

Study Sites (1)

KBC Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Depression; Cardiovascular Diseases

Interventions

Sertraline; Escitalopram; Methods

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Investigative Techniques

Study Officials

• Alma Mihaljević Peleš, Prof.

  Head of Department of Psychiatry

  STUDY CHAIR

Central Study Contacts

Sara Medved, MD

CONTACT

+38512388394; smedved@kbc-zagreb.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be assigned to intervention group if they have symptoms of depression, i.e. to control group if they do not show depressive symptoms. A psychiatrist will then, according to clinical impression, prescribe either sertraline or escitalopram to intervention group (i.e. groups). Both groups (sertraline and escitalopram) will be described as one intervention group.

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)