Prospective Study of the Evaluation of Disease contRol and the Quality of Life of Patients With depressiOn and With or Without aNxiety disOrders in the Greek populatIon (PRONOI)

Multi-center, Open, Non-invasive, Prospective, Clinical Observational Study in Patients in Greece With Depression and Generalized Anxiety Disorder Treated With Sitalopram and Not Satisfactorily Controlled.

Depression is a psychiatric disorder that affects mood, thoughts and is usually accompanied by physical annoyances. It affects the person's eating habits, his sleep, the way he sees himself and the way he thinks and understands. Depressed emotion has great tension, lasts longer and leads to a reduction in the person's functioning in many areas of his life.

Generalized Anxiety Disorder (GAD) is the psychiatric disorder characterized by a multitude of diverse organic responses as well as a generalized, persistent and indeterminate anxiety that covers almost all of the individual's activities. It is a diffuse and intense negative mood and anxiety that is present for most of the day and whose exact causes are often undetectable.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorders

Detailed Description

The Hamilton Depression Scale is the most widely used scale for measuring the severity of depression worldwide. It was designed to measure the severity of depression in already diagnosed patients with major depressive disorder. It includes 17 entries rated from 0 to 2 or from 0 to 4, thus giving a total score ranging from 0-50.

The scores are scored through the symptoms reported by the patient during the interview, the evaluator's observations and the information collected from third parties (relatives, nurses). The markings do not distinguish between the intensity and frequency of the symptoms, but these two should be equally at the discretion of the assessor. The scale covers the condition of the patient in the week preceding the mark for most symptoms, except for sleep disorders related to the last three days.Health-related quality of life is calculated using weighted questionnaires focusing on the general health level of the individual or the impact of specific diseases on the quality of life of the patient.

These questionnaires are based on a common theoretical background, according to which the measurement of biological functionality is a basic, but not sufficient, assessment of health. Apart from the good functioning of organic systems, which represents the traditional biomedical model of health, the need for an assessment of the general well-being and functioning of the individual in all areas of his life is also important.

The EQ-5D questionnaire is a self-completed tool for measuring the quality of life and consists of two parts:

The first part records the person's health profile. Five dimensions are used, referring to (a) mobility, (b) self-handling, (c) routine activities, (d) pain-discomfort and (e) stress-depression. Each of these dimensions takes three values: 1 = no problem, 2 = some problems, 3 = significant problems. Altogether, three health situations are recorded, representing 243 cases. The best mental state is described as "11111", meaning that there is no problem in terms of mobility, self-care, routine activities, pain and anxiety. The worst mental health status gets the "33333" values, which means significant problems in the above five dimensions.

The second part presents a visual analogue scale (VAS) in the form of a "health thermometer", which takes values from 0 = worse mental health to 100 = excellent mental health. Intermediate values of the optical proportional scale indicate intermediate health status. This scale is based on the person's subjective assessments of his / her state of health.

Using the EQ-5D, it is possible to estimate the benefit enjoyed by the individual from different health situations.

The HAM-A scale was one of the first assessment scales developed to measure the severity of anxiety symptoms and is still used up to now in both clinical and research environments.

The scale consists of 14 elements, which are determined by a series of symptoms, and measures both mental (mental stimulation and psychological discomfort as well as physical anxiety (physical anxiety disorders).

Each question is scored on a scale of 0 (none) to 4 (very serious), with a total score of 0 to 56. A score of less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 mild to severe.

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece
    • Private Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with depression and anxiety disorders

Description

Inclusion Criteria:

• Signed informed consent form
• Male or female asthma patients over 18 years of age
• Compliance with treatment
• Compliance with study procedures
• Patients already receiving or to receive citalopram
• Patients not adequately controlled by citalopram
• Patients not adequately controlled by citalopram and at the same time having a generalized anxiety disorder
• Patients not regulated at all

Exclusion Criteria:

• Unsigned patient consent
• Male or female asthma patients under 18 years of age
• Non-compliance with treatment
• Non-compliance in study procedures
• Patients who do not meet the Product SmPC criteria
• Patients receiving MAO inhibitors

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control	Change in HAM-D scale The Hamilton Depression Scale is the most widely used scale for measuring the severity of depression worldwide. It was designed to measure the severity of depression in already diagnosed patients with major depressive disorder. It includes 17 entries rated from 0 to 2 or from 0 to 4, thus giving a total score ranging from 0-50.	6 months
Disease Control	Change in HAM-A scale The HAM-A scale was one of the first assessment scales developed to measure the severity of anxiety symptoms and is still used up to now in both clinical and research environments. The scale consists of 14 elements, which are determined by a series of symptoms, and measures both mental (mental stimulation and psychological discomfort as well as physical anxiety (physical anxiety disorders). Each question is scored on a scale of 0 (none) to 4 (very serious), with a total score of 0 to 56. A score of less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 mild to severe.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Change in EuroQol-5D scale The EQ-5D questionnaire is a self-completed tool for measuring the quality of life and consists of two parts: The first part records the person's health profile. Five dimensions are used, referring to (a) mobility, (b) self-handling, (c) routine activities, (d) pain-discomfort and (e) stress-depression. Each of these dimensions takes three values: 1 = no problem, 2 = some problems, 3 = significant problems. Altogether, three health situations are recorded, representing 243 cases. The best mental state is described as "11111", meaning that there is no problem in terms of mobility, self-care, routine activities, pain and anxiety. The worst mental health status gets the "33333" values, which means significant problems in the above five dimensions.	6 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: quality of life, citalopram, quetiapine, pregabalin
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 2017-CTL-EL-76

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No