A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

Stress Disorders, Post-Traumatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033069
• Other study ID #: 331-201-00061
• Status: Completed
• Phase: Phase 2
• Start date: January 26, 2017
• Est. completion date: November 12, 2018

Study information

• Verified date: November 2021
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: November 12, 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Brexpiprazole
Brexpiprazole oral tablets.
• Sertraline
Sertraline oral capsules.
• Brexpiprazole Matching Placebo
Brexpiprazole matching placebo oral tablets.
• Sertraline Matching Placebo
Sertraline matching placebo oral capsules.

Locations

Country	Name	City	State
United States	Investigational Site	Atlanta	Georgia
United States	Investigational Site	Bellaire	Texas
United States	Investigational Site	Bellflower	California
United States	Investigational Site	Berlin	New Jersey
United States	Investigational Site	Beverly Hills	California
United States	Investigational Site	Bradenton	Florida
United States	Investigational Site	Brooklyn	New York
United States	Investigational Site	Cedarhurst	New York
United States	Investigational Site	Charleston	South Carolina
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Cincinnati	Ohio
United States	Investigational Site	Colorado Springs	Colorado
United States	Investigational Site	Decatur	Georgia
United States	Investigational Site	Everett	Washington
United States	Investigational Site	Fort Lauderdale	Florida
United States	Investigational Site	Fort Myers	Florida
United States	Investigational Site	Gainesville	Florida
United States	Investigational Site	Glendale	California
United States	Investigational Site	Jacksonville	Florida
United States	Investigational Site	Las Vegas	Nevada
United States	Investigational Site	Lincoln	Rhode Island
United States	Investigational Site	Little Rock	Arkansas
United States	Investigational Site	Media	Pennsylvania
United States	Investigational Site	Memphis	Tennessee
United States	Investigational Site	National City	California
United States	Investigational Site	New York	New York
United States	Investigational Site	Norristown	Pennsylvania
United States	Investigational Site	North Miami	Florida
United States	Investigational Site	Oceanside	California
United States	Investigational Site	Oceanside	California
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Orange	California
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	Portland	Oregon
United States	Investigational Site	Princeton	New Jersey
United States	Investigational Site	Raleigh	North Carolina
United States	Investigational Site	Redlands	California
United States	Investigational Site	Riverside	California
United States	Investigational Site	Rochester	New York
United States	Investigational Site	Rogers	Arkansas
United States	Investigational Site	Roswell	Georgia
United States	Investigational Site	Saint Louis	Missouri
United States	Investigational Site	Salem	Oregon
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	San Diego	California
United States	Investigational Site	San Marcos	California
United States	Investigational Site	Tampa	Florida
United States	Investigational Site	Torrance	California
United States	Investigational Site	Tuscaloosa	Alabama
United States	Investigational Site	Wichita Falls	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from categories: Category B:Intrusion symptoms (5 items); Category C:Avoidance symptoms (2 items); Category D:Cognition and mood symptoms (7 items); Category E:Arousal and reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B,C,D,E. Each symptom was scored 0 (Absent) to 4 (Extreme/incapacitating), to yield a score with range 0-80. Higher scores=worse outcome. Mixed model repeated measure (MMRM) was used for analysis.	Baseline, Week 12