Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Changes in the score on the Hamilton Rating Scale for Depression (HAM-D). Measurement time: Pre-enrollment and on days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months
Key secondary outcomes:
Changes in the score on the Clinical Global Impression scale (CGI). Measurement time: Days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months Change in the score on the Sexual Dysfunction Scale of the Massachusetts General Hospital Days 0, 42, 70 and 6 months Weight (Kgs). Measurement time: Pre-enrollment and on days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months Adverse Event (AE). Measurement time: Days 7, 14, 21, 28, 42, 56, 70 and 6 months -Type of EA (name of the AE) -Intensity of AE (mild, moderate, severe) -Severity of AE (Serious or not) -Duration of the AE (to be recorded over time) -Attitude to drugs (to be recorded if there were changes, dose modification, interruption or discontinuance of treatment) -Result of the AE (1 Cured, 2 Enhanced, 3 persistent,4 Sequelae) -Causal Relationship of the AE (definite, likely, probable, possible, unrelated, unknown) -Treatment indicated (treatment received by each patient for the AE occurred)