Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Brexpiprazole; Paroxetine; Sertraline

Criteria

Inclusion Criteria:

• The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).

• The patient has a Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at Screening and Baseline Visits.

• The reported duration of the PTSD is at least 3 months.

Exclusion Criteria:

• The index traumatic event that led to development of PTSD took place more than 15 years before screening.

• The patient has a severe personality disorder that in the investigator's opinion may interfere with the conduct of the study.

• The patient is at significant suicidal risk.

Other inclusion and exclusion criteria may apply.