Summary:
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.
Inclusion Criteria:
- Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- Subjects who have PTSD, diagnosed according to DSM-5
- Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening
- Traumatic event that caused the onset of PTSD must have occured after the age of 16
- Subjects cannot be receiving disability payments related to their PTSD diagnosis