Statistics
SE, TSD
TSD
Since the study was not primarily powered to assess the pharmacodynamic effects of JNJ-54175446, descriptive statistics were performed for HDRS17, QIDS-SR POMS, PILT and SHAPS, with mean ± SD values and changes from baseline being summarized by treatment group at the respective scheduled time points per instrument. Data were presented graphically for individual subject values or as mean ± SE values over time.In addition to the descriptive statistics, for the HDRS17 total score a mixed-effects model using repeated measures was performed for change from baseline (day -1) to day 10. The model included baseline score as covariate, and antidepressant treatment status (treatment naïve or SSRI treatment), day, treatment and day-by-treatment interaction as fixed effects, and a random subject effect.In blood, both in vivo and ex-vivo, mean values and mean changes from baseline in IL-1β levels were determined and compared to placebo.Following review and interpretation of the exploratory results, a pattern became apparent for the effects of JNJ-54175446 on hedonic tone during the TSD period: all patients receiving JNJ-54175446 before the recovery night (which were both groups A and B, as group B received their loading dose on the last day of TSD) did not demonstrate changes in PILT ‘total amount lost’, whereas placebo group C demonstrated a clear improvement following recovery sleep. Therefore, specific additional exploration of hedonic tone as assessed with the SHAPS and the PILT total amount lost was warranted. To this end a post-hoc analysis was performed to further assess the effect of JNJ-54175446 compared to placebo on TSD induced decrease of the SHAPS total score and PILT total amount lost, between day 3 and day 5 using an unpaired 