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

Lundbeck

Status and phase: Terminated; Phase 3

Conditions: Post-traumatic Stress Disorder; PTSD

Treatments: Drug: Brexpiprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987960

14865A

2012-004982-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 417 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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417 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)

Treatment:

Drug: Placebo

Brexpiprazole

Experimental group

Description:

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.

Treatment:

Drug: Brexpiprazole