Depression Clinical Trial
— PRONOIOfficial 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.
NCT number | NCT03317262 |
Other study ID # | 2017-CTL-EL-76 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | March 1, 2019 |
Verified date | March 2018 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 800 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Greece | Private Office | Larissa |
Lead Sponsor | Collaborator |
---|---|
Elpen Pharmaceutical Co. Inc. |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 |
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