Depression Clinical Trial
Official title:
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.
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.
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