ClinicalTrials.gg
CompletedNCT03317262PRONOIUpdated May 13, 2019

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

An observational study in Depression and Anxiety Disorders, sponsored by Elpen Pharmaceutical Co. Inc.. Completed at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-13.

Sponsored by Elpen Pharmaceutical Co. Inc. · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 28 studies in Depression with a site in Greece — 12 open to participants now, 14 under way, 4 of them phase 3. Depression · Greece.

Started
2018
the only one that year
Observational
8 of 28
2 open now
Registered
5th of 28
by date
Lead sponsor
1 of 28
Elpen Pharmaceutical Co. Inc.

Among the 28 studies in Depression with a site in Greece, this one is the only one that started in 2018, is one of 8 observational ones, and was the 5th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

12 of the 28 studies in Depression with a site in Greece are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the 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.

03

Conditions studied

  • Depression
  • Anxiety Disorders

Keywords

  • quality of life, citalopram, quetiapine, pregabalin
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with depression and anxiety disorders

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Private Office
    Larissa, Greece
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Mar 2019, 12 months.

Of 33 industry-sponsored observational studies under Depression, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 12 months is below that.

Counting every sponsor, half of 493 studies reached it within 32 months; a quarter within 13 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Oct 23, 2017
StartActual
Mar 1, 2018
Primary completionActual
Mar 1, 2019
CompletionActual
Mar 1, 2019
Last update
May 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03317262
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Mar 1, 2018
Primary completion
Mar 1, 2019
Completion
Mar 1, 2019
Last update
May 13, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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