A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder
調査の概要
詳細な説明
The patients will be randomly assigned to 3 weeks of augmentation therapy (in addition to the antidepressant medication, which will be continued) with either: 1) aerobic exercise or 2) stretching exercise (control group). Random assignment to each group will be stratified according to previous response to treatment as determined by a psychiatrist and review of the Antidepressant Treatment History Form (ATHF) and by gender.
Severity of depression will be rated at the first baseline visit and every week during the exercise program using the Hamilton Depression Scale (HAM-D 21 items), Clinical Global Impression Scale (CGI) (observer-rated) and Beck Depression Inventory (BDI) and Visual Analog Scale (self-rated).
Blood samples will be obtained four times during the study - before and after the first exercise session and before and after the last exercise session. The blood taken before the exercise sessions will be used to assay thyroxine, cortisol, insulin, opioid peptides and cytokines such as IL-6 and TNF-α in the plasma. The blood taken after the exercise sessions will be used to re-examine variables expected to be altered immediately after exercise such as cortisol, opioid peptides, catecholamines and cytokines.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Jerusalem、イスラエル
- Hadassah Medical Organization
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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
説明
Inclusion Criteria:
- Diagnosis of Major Depressive Episode (MDE) in the context of MDD according to DSM-IV criteria, without psychotic features.
- Hamilton Depression Scale (21 items, HAM-D) total>14 with item 1 (depressed mood) >2.
- Physical capability to perform aerobic exercise or stretching exercise.
- Competent and willing to give written informed consent
Exclusion Criteria:
- Current, significant physical illness that will preclude exercise training.
- Any physical impairment that can interfere with exercise training.
- Current psychotic features.
- Treatment with electroconvulsive therapy.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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 |
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response of depressive symptoms- reduction in HAM-D score at the end of the follow-up period
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二次結果の測定
結果測定 |
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入院期間
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reduction in pretreatment BDI score
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remission according to HAM-D score
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remission according to BDI score
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changes in plasmatic measurements before and after the first and last exercise
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協力者と研究者
捜査官
- 主任研究者：tal Shahar, MD、Hadassah Medical Organization
研究記録日
主要日程の研究
研究開始
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 (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。
大鬱病性障害の臨床試験
controlled physical exerciseの臨床試験
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