The Pathology of a Cross-over Trial (Thiazesim—A New Anti-depressant Drug)

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Abstract
A pilot uncontrolled study of a new preparation, thiazesim, suggested that it had antldepressant activity. A wlthln-patlents controlled trial comparing 1 week''s drug treatment with 1 week on placebo failed to confirm this, but chemical studies showed a persistent excretion of the drug during the 2nd placebo week in those patients receiving the drug in the 1st week. It is possible that the drug continued to act in the 2nd week, and the trial must be considered inconclusive. This illustrates the importance of chemical and metabolic studies of a new drug in man before a decision can be made on whether to organize a between- or wlthln-subjects trial. A matched between-subjects trial is indicated for the assessment of anti-depressant activity of thiazesim.