Designing long-term clinical trials in affective disorders.
Long-term clinical trials in affective disorders have become increasingly important, but their methodology continues to impose a major challenge. An ideal design can be developed but is difficult to implement. The advantages and disadvantages of different designs (mirror image, double-blind study controlled with placebo, and/or standard and discontinuation studies) are described and compared. Shortcuts in design usually carry a high risk of false-negative findings and result in a waste of resources. An abbreviated version was presented at the European Consensus Conference on Long-term Clinical Trials in Zurich, Switzerland, October 1992.
Department of Psychiatry, University of Ottawa, Royal Ottawa Hospital, Ontario, Canada.
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D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D006801:Humans; D019964:Mood Disorders / Q000188:drug therapy / Q000517:prevention & control*; D010919:Placebos; D012008:Recurrence; D012107:Research Design
D010919:Placebos