Primary endpoint

For the HAM-D, the FDA usually requires a minimal meaningful improvement of a 50% decrease to a score of less than 10. Although a rating score reduction of 50% is accepted by the FDA, clinicians consider remission rate as a more meaningful endpoint. Remission rate is defined as a score of less than 12 according to the MADRAS scale at any point in time during the study. The MADRAS score decreases as depression symptoms improve. MADRAS measures the severity of a number of depressive symptoms including mood and sadness, tension, sleep, appetite, energy, concentration, suicidal ideation, and restlessness and is gaining in use in the European Union.

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