To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis
Predicting Factors for Depression in Patients With MS in Argentina
調査の概要
状態
条件
詳細な説明
Multiple sclerosis is a chronic, demyelinating disease of the central nervous system and is considered to be one of the most common cause of neurological disability in young adults. The clinical and pathophysiological characteristics of the disease lead to the association of several conditions over time, among which the depression and/or the depression symptoms are one of the most important ones. The underlying mechanism of depression is not clear and the etiology of depression is considered to be multifactorial and especially associated to the psychosocial stress, to the presence of focal demyelinating lesions and to the immune malfunction. Several scales like Beck Depression Inventory Fast Screen (BDI FS), Mini Mental State Examination (MMSE), Hamilton Depression Rating Scale (HDRS) have been used to objectify the presence of depression symptoms in subjects with MS.
OBJECTIVES
Primary objective:
- Identification of the predictive factors for the development of depression symptoms in subjects with MS in Argentina
Secondary objective:
- Evaluation of the proportion of subjects that develop depression symptoms during the follow up
The subjects will be managed with the clinical and therapeutic elements that the treating doctors considered appropriate, without modifying their decisions due to the subjects' inclusion into the study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Buenos Aires
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Capital Federal、Buenos Aires、アルゼンチン、1015
- Instituto de Investigacion Neurológica (Uruguay 840)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Subjects aged between 18 65 years of both sexes
- Subjects with established MS diagnosis according to the revised Mc Donald criteria - 2005 in any of its clinical forms
- Subjects with signed informed consent
- Subjects wiling to follow the study procedure
Exclusion Criteria:
- Subjects with diagnosis of depression at the moment of the initial evaluation
- Subjects receiving antidepressant drugs at the moment of the initial evaluation
- Subjects with moderate or severe cognitive impairment
- Antecedents of any other psychiatric disease
- Subjects that were receiving or have received any experimental treatment during the 6 months before the inclusion
研究計画
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 |
|---|---|---|
|
Apparition and/or modification of depression symptoms through the agreed assessments
時間枠：Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months)
|
The assessments will include Expanded Disability Status Scale, Hamilton Depression Rating Scale, Mini Mental State Examination, Beck Depression Inventory, clock drawing test and findings in magnetic resonance imaging.
|
Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of subjects that developed depression symptoms during the study compared to the total population of subjects enrolled in the study
時間枠：Initial visit (Day 0) to 24 months
|
Initial visit (Day 0) to 24 months
|
協力者と研究者
捜査官
- 主任研究者：Roberto Rey, Neurologist、Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。