このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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 (PRONOI)

2019年5月10日 更新者:Elpen Pharmaceutical Co. Inc.

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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

観察的

入学 (実際)

800

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients diagnosed with depression and anxiety disorders

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Disease Control
時間枠: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.

6 months
Disease Control
時間枠: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.

6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Quality of Life
時間枠:6 months

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年3月1日

一次修了 (実際)

2019年3月1日

研究の完了 (実際)

2019年3月1日

試験登録日

最初に提出

2017年10月18日

QC基準を満たした最初の提出物

2017年10月18日

最初の投稿 (実際)

2017年10月23日

学習記録の更新

投稿された最後の更新 (実際)

2019年5月13日

QC基準を満たした最後の更新が送信されました

2019年5月10日

最終確認日

2018年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2017-CTL-EL-76

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する