Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033069
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date January 4, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date November 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Mean change in baseline of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score [ Time Frame: Baseline - Week 12 ]
CAPS-5 is a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by the DSM-5.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
CAPS-5 Score [ Time Frame: Baseline - Week 12 ]
Efficacy will be measured by reviewing mean change from baseline in CAPS-5 total score.
Change History Complete list of historical versions of study NCT03033069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder
Official Title  ICMJE A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder
Brief Summary To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy (Zoloft) 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 subjects with PTSD.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • Drug: Brexpiprazole (OPC-34712)
  • Drug: Sertraline
    Other Name: Zoloft
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Brexpiprazole Monotherapy
    Flexible dose
    Intervention: Drug: Brexpiprazole (OPC-34712)
  • Active Comparator: Brexpiprazole & Zoloft (sertaline) Combination Therapy
    Flexible dose
    Interventions:
    • Drug: Brexpiprazole (OPC-34712)
    • Drug: Sertraline
  • Active Comparator: Zoloft (setraline) monotherapy
    Flexible dose
    Intervention: Drug: Sertraline
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2018)
336
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
332
Actual Study Completion Date  ICMJE November 8, 2018
Actual Primary Completion Date November 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and Female subjects 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033069
Other Study ID Numbers  ICMJE 331-201-00061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP