Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

CAPS-5 is a structured interview designed to assess PTSD diagnostic status & symptoms severity as defined by DSM-5. CAPS-5 total score was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from following categories: Category B: Intrusion symptoms (5 items); Category C: Avoidance symptoms (2 items); Category D: Cognition & mood symptoms (7 items); Category E: Arousal & reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B, C, D, E. Each symptom was scored 0= Absent to 4= Extreme/incapacitating, yielding a score range of 0-80. Higher scores indicate worse outcome. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), & an interaction term of treatment by visit, & include the interaction term of baseline values of CAPS-5 total score by visit as a covariate.

The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess it, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The score 0 (not assessed) was be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7. A higher score on the CGI-S represents a higher severity of disease. LS mean was determined by MMRM method with fixed class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), & an interaction term of treatment by visit, & include the interaction term of baseline values of CAPS-5 total score by visit as a covariate.

The B-IPF is a short patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function on a 7-point Likert scale (0 = not at all to 6 = very much, and a not applicable option) with a recall period of 30 days. It measures the concepts of romantic relationships, parenting, family, friendships and socializing, work, education, and self-care. Total score ranges from 0-100 and is calculated by summing the completed scale items, dividing by the maximum possible score of all items and multiplying by 100. Higher scores indicate greater impairment. LS mean was determined by MMRM method with fixed class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), & an interaction term of treatment by visit, & include the interaction term of baseline values of CAPS-5 total score by visit as a covariate.