Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
Post Traumatic Stress Disorder
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD
Eligibility Criteria
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, and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.
Exclusion Criteria:
- The index traumatic event that led to the develop of PTSD took place > 9 years before screening.
- The index traumatic event occurred before age 16.
- Subjects who have experienced a traumatic event within 3 months of screening.
- Subjects who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.
Sites / Locations
- For additional information regarding sites, contact 844-687-8522
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
Brexpiprazole + Sertraline
Sertraline
Placebo
3 pills: Dose of up to 3 mg /day may be administered of brexpiprazole, dose up to 150 mg/day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
3 pills: Dose up to 150 mg/ day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
3 pills: Brexpiprazole-matched placebo tablets and Sertraline-matched placebo tablets may be administered. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.