دانلود مقاله ISI انگلیسی شماره 74892
عنوان فارسی مقاله

مسائل طراحی منحصر به فرد در کارآزمایی های بالینی بیماران مبتلا به اختلال عاطفی دو قطبی

کد مقاله سال انتشار مقاله انگلیسی ترجمه فارسی تعداد کلمات
74892 2003 13 صفحه PDF سفارش دهید محاسبه نشده
خرید مقاله
پس از پرداخت، فوراً می توانید مقاله را دانلود فرمایید.
عنوان انگلیسی
Unique design issues in clinical trials of patients with bipolar affective disorder
منبع

Publisher : Elsevier - Science Direct (الزویر - ساینس دایرکت)

Journal : Journal of Psychiatric Research, Volume 37, Issue 1, January–February 2003, Pages 61–73

کلمات کلیدی
اختلال دو قطبی؛ کارازمایی بالینی؛ متقاطع؛ آمار؛ مورد تک؛ روش شناسی
پیش نمایش مقاله
پیش نمایش مقاله مسائل طراحی منحصر به فرد در کارآزمایی های بالینی بیماران مبتلا به اختلال عاطفی دو قطبی

چکیده انگلیسی

Two National Institute of Mental Health-sponsored meetings of experts on bipolar illness (in 1989 and 1994) noted a paucity of clinical psychopharmacological trials in this illness which has now extended over the past two decades. One of the reasons elucidated for this neglect was a lack of agreement in the field as to what constituted an optimal clinical trial design, consequently resulting in low-priority scores for funding of studies in bipolar illness. In this paper, we note some of the characteristics of bipolar illness that make it particularly difficult to study and find such agreed upon trial designs. Some of the assets and liabilities of the well-accepted traditional parallel group, placebo-controlled, randomized clinical trial (RCT) are reviewed, and a series of other potential design options, such as crossover, enrichment, off-on-off-on (B-A-B-A), and N-of-1 trials, are discussed that may help to better address some of the unique clinical characteristics of bipolar illness. Finally, a variety of statistical approaches to analyzing data in off-on-off-on trial designs, and in helping to predetermine necessary durations of clinical trials in individual patients with bipolar disorders, are suggested. Acceptance of a wider variety of clinical trial designs may help facilitate the funding and accelerate the acquisition of new data on treatment of bipolar illness.

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