Study Outcomes
Depression, PTSD, depressive symptoms
ADVERSE EVENTS, SECONDARY
The primary outcome was clinical response status, defined as a 30% or greater reduction in total CAPS (past week) score from baseline to 4 weeks. On the basis of a binary statistical selection rule, an absolute difference in the proportion of treatment vs control group responders of 15% would be considered a clinically relevant difference.The secondary outcome measures included the following: (1) proportion of clinical responders at 12 weeks, (2) trajectories of continuous CAPS scores, and (3) percentage of study drug–related adverse events. The descriptive outcomes included changes in (1) PTSD symptom subscale scores, (2) depressive symptoms (Beck Depression Inventory total score),