Predictors of the Outcome of Late Life Depression
Clinical Characteristics and Structural Changes in Magnetic Resonance Imaging: Importance for the Outcome of Late Life Depression
調査の概要
状態
条件
詳細な説明
The relevance of depression prevention and treatment in older people tend to raise in future years, considering the rapid increase of the elderly population in Brazil and the growing impact of depression (the third cause of global burden of diseases in the world according to the World Health Association 2004 report). The association between structural brain changes and treatment response in patients with late-life depression (LLD) remains an intriguing area of research. Predictors of response to pharmacological treatment of major depressive disorder will be investigated in 120 elderly patients, who will be included in a naturalistic clinical trial, that will evaluate psychopathology, personality traits, cognitive performance, brain structural changes and genetic polymorphisms. Patients will be followed for 18 months with a treatment algorithm for depression and will be evaluated monthly until 6th month and every 3 months, up to 18 months, to assess factors associated to response to treatment.
Patients who are in the antidepressant treatment group and does not reach remission (MADRS score <or =8) until 3 months of pharmacological treatment will be invited to be part of a psychoeducation program. If the patient accepts the psychoeducation intervention, he will be randomized to psychoeducation (pharmacological treatment plus psychoeducation) or treatment as usual (only pharmacological treatment). The psychoeducation program consists of 10 individual weekly sessions, conducted by a trained psychologist who will explain the main concepts of depression and its symptoms, the importance of adhering to treatment, the main side effects of pharmacological treatment, and how to cope with daily difficulties.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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São Paulo、ブラジル、05403-010
- University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
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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:
- 60 years old
- Major depression (DSMIV-TR)
- Evaluated with MINI
- Willing to participate.
Exclusion Criteria:
- Less than 60 years old
- Dementia syndrome
- Delirium or other organic mental disorders
- Alcohol/drug dependence
- Anxiety disorders, or other psychiatric disorders, and not willing (or not able) to participate
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Antidepressant treatment
According to their previous treatment history and clinical presentation, patients may take: Sertraline 50-250mg/day for 1 year or Escitalopram 10-20mg/day for 1 year or Mirtazapine 15-45mg/day for 1 year or Venlafaxine 37,5-300mg/day for 1 year or Lithium 300-900mg/day for 1 year. |
Sertraline 50-250mg/day for 1 year or Escitalopram 10-20mg/day for 1 year or Mirtazapine 15-45mg/day for 1 year or Venlafaxine 37,5-300mg/day for 1 year or Lithium 300-900mg/day for 1 year.
他の名前：
Patients who are in the antidepressant treatment group and does not reach remission (MADRS score |
|
Antidepressant treatment & Psychoeducation intervention
Antidepressant treatment and psych education program (10 weekly sessions).
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Sertraline 50-250mg/day for 1 year or Escitalopram 10-20mg/day for 1 year or Mirtazapine 15-45mg/day for 1 year or Venlafaxine 37,5-300mg/day for 1 year or Lithium 300-900mg/day for 1 year.
他の名前：
Patients who are in the antidepressant treatment group and does not reach remission (MADRS score |
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 |
|---|---|---|
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Change from Baseline Montgomery-Asberg Depression Scale (MADRS) below 8 during the initial 12 weeks of the study and remained below 8 until 18 months
時間枠：18 months
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The investigators will consider patients remitted when their MADRS scale score decreased below 8 during the initial 12 weeks of the study and remained below 8 until 24 weeks.
All patients whose MADRS scores decreased to 8 but rose above 8 during the study or whose MADRS score remained at 8 or above throughout the study were considered not remitted
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18 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline Clinical Global Impression (CGI) up to 18 months
時間枠：18 months
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It will be applied on 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th, 15th, and 18th months of follow-up. On the 6th, 12th, and 18th months, the Mini Mental State Examination (MMSE), the Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG)and the Bayer Activities of Daily Living Scale (B-ADL) will be applied. |
18 months
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Change from baseline Hamilton-D Scale (HAM-D) up to 18 months
時間枠：18 months
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It will be applied on 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th, 15th, and 18th months of follow-up. On the 6th, 12th, and 18th months, MMSE, the CAMCOG and the B-ADL will be applied. |
18 months
|
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Change from baseline Mini Mental State Examination (MMSE) up to 18 months
時間枠：18 months
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It will be applied on 1st, 12th, and 18th months of follow-up.
On the 6th, 12th, and 18th months, MMSE, the CAMCOG and the B-ADL will be applied.
|
18 months
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Change from baseline Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG) up to 18 months
時間枠：18 months
|
It will be applied on 1st, 12th, and 18th months of follow-up.
|
18 months
|
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Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months
時間枠：18 months
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It will be applied on 1st, 12th, and 18th months of follow-up.
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18 months
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協力者と研究者
捜査官
- スタディディレクター：Cassio MC Bottino, phD、Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
- 主任研究者：Salma Rose Imanari Ribeiz, phD、Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
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 (実際)
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
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