Antidepressants are used for long periods of time and until recently there were no formal requirements for establishing efficacy in the maintenance phase or the prophylactic phase of the treatment of depression. The CPMP guidelines advise regulatory authorities in the EEC to consider the efficacy of antidepressants in the medium and the long term separately from efficacy in the treatment of the acute episode. This paper reviews the efficacy of antidepressants in continuation treatment and prophylactic treatment of unipolar depression. Prophylactic studies are difficult and time consuming and it is important to adopt adequate trial methodology. The minimum criteria for the demonstration of prophylactic efficacy are presented.
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