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

NCT03317262 | Completed

• 1 other identifier: 2017-CTL-EL-76
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Anxiety Disorders

Keywords

quality of life, citalopram, quetiapine, pregabalin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Quality of Life

  6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with depression and anxiety disorders

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Private Office

Larissa, Greece

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2018-03

Locations

GR (1)