Clinical trial NCT03033069: A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2017-01-26
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.

Detailed description: This trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult participants with PTSD.

This study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.

Eligibility criteria: Inclusion Criteria:

* Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)

Exclusion Criteria:

* Index trauma event \>15 years before screening
* Index trauma event at age \<16
* Any traumatic event within 3 months of screening

Primary outcomes:
measure: Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Rogers
country: United States
facility: Investigational Site
state: Arkansas
city: Bellflower
country: United States
facility: Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Investigational Site
state: California
city: Glendale
country: United States
facility: Investigational Site
state: California
city: National City
country: United States
facility: Investigational Site
state: California
city: Oceanside
country: United States
facility: Investigational Site
state: California
city: Oceanside
country: United States
facility: Investigational Site
state: California
city: Orange
country: United States
facility: Investigational Site
state: California
city: Redlands
country: United States
facility: Investigational Site
state: California
city: Riverside
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: San Marcos
country: United States
facility: Investigational Site
state: California
city: Torrance
country: United States
facility: Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Investigational Site
state: Colorado
city: Bradenton
country: United States
facility: Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site
state: Florida
city: North Miami
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Tampa
country: United States
facility: Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Saint Louis
country: United States
facility: Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Investigational Site
state: New Jersey
city: Princeton
country: United States
facility: Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Investigational Site
state: New York
city: Cedarhurst
country: United States
facility: Investigational Site
state: New York
city: New York
country: United States
facility: Investigational Site
state: New York
city: Rochester
country: United States
facility: Investigational Site
state: New York
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Salem
country: United States
facility: Investigational Site
state: Oregon
city: Media
country: United States
facility: Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Investigational Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Investigational Site
state: Tennessee
city: Bellaire
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Investigational Site
state: Texas
city: Everett
country: United States
facility: Investigational Site
state: Washington
Study officials:
References: