Conditions: Post-traumatic Stress Disorder PTSD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 417
Healthy volunteers: no

Brief summary:
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

Detailed description:

Arms:
arm 1: Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) arm 2: Brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day.

Interventions: intervention 1: Placebo intervention 2: Brexpiprazole
Intervention descriptions: intervention 1: Once daily, tablets, orally intervention 2: 1 to 3 mg/day, once daily dose, tablets, orally

Protocol document: