Sample size calculation
TSD
This safety and tolerability study involved TSD as an exploratory proof-of-concept intervention to induce acute mood improvement and was preceded and/or followed by JNJ-54175446 and/or placebo. Hence, it was impossible to make any plausible assumptions of the effect sizes and/or the interactions between sleep deprivation, treatment (duration) and mood changes. Therefore, formal statistical calculation of sample size was not appropriate and was not performed. Generally speaking, a sample size of 60 patients or more represents the customary size employed in early development studies designed to allow clinical assessment of safety and tolerability and is sufficient to demonstrate clinical mood elevating effects of sleep deprivation and/or antidepressant medication [