DepressionPRONOINCT03317262
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 of Depression and Anxiety Disorders, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Anxiety Disorders
- How many people
- 800 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with depression and anxiety disorders
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Depression, Anxiety Disorders
- Keywords
- quality of life, citalopram, quetiapine, pregabalin
- Medical subject headings
- Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317262
- Sponsor's protocol ID
- 2017-CTL-EL-76
- Acronym
- PRONOI
- Status last verified
- Mar 2018
- First submitted
- 18 Oct 2017
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03317262
- Acronym / sponsor ID
- PRONOI / 2017-CTL-EL-76
- Conditions
- Depression, Anxiety Disorders
- Keywords
- quality of life, citalopram, quetiapine, pregabalin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with depression and anxiety disorders
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Control
Time frame: 6 months
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.
Disease Control
Time frame: 6 months
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.
1 secondary outcome
Quality of Life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety Disorders, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.