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

November 10, 2021 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
        • Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Investigational Site
      • Rogers, Arkansas, United States, 72758
        • Investigational Site
    • California
      • Bellflower, California, United States, 90706
        • Investigational Site
      • Beverly Hills, California, United States, 90210
        • Investigational Site
      • Glendale, California, United States, 91206
        • Investigational Site
      • National City, California, United States, 91950
        • Investigational Site
      • Oceanside, California, United States, 92056
        • Investigational Site
      • Oceanside, California, United States, 92054
        • Investigational Site
      • Orange, California, United States, 92868
        • Investigational Site
      • Redlands, California, United States, 92374
        • Investigational Site
      • Riverside, California, United States, 92506
        • Investigational Site
      • San Diego, California, United States, 92103
        • Investigational Site
      • San Marcos, California, United States, 92078
        • Investigational Site
      • Torrance, California, United States, 90502
        • Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Investigational Site
      • Fort Lauderdale, Florida, United States, 33319
        • Investigational Site
      • Fort Myers, Florida, United States, 33912
        • Investigational Site
      • Gainesville, Florida, United States, 32607
        • Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Investigational Site
      • North Miami, Florida, United States, 33161
        • Investigational Site
      • Orlando, Florida, United States, 32806
        • Investigational Site
      • Orlando, Florida, United States, 32801
        • Investigational Site
      • Tampa, Florida, United States, 33614
        • Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Investigational Site
      • Decatur, Georgia, United States, 30030
        • Investigational Site
      • Roswell, Georgia, United States, 30076
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Investigational Site
      • Princeton, New Jersey, United States, 08540
        • Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Investigational Site
      • Cedarhurst, New York, United States, 11516
        • Investigational Site
      • New York, New York, United States, 10128
        • Investigational Site
      • Rochester, New York, United States, 14618
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Site
      • Oklahoma City, Oklahoma, United States, 73118
        • Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97214
        • Investigational Site
      • Salem, Oregon, United States, 97301
        • Investigational Site
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Investigational Site
      • Norristown, Pennsylvania, United States, 19403
        • Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Investigational Site
      • San Antonio, Texas, United States, 78229
        • Investigational Site
      • Wichita Falls, Texas, United States, 76309
        • Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brexpiprazole + Sertraline
Participants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.
Drug: Brexpiprazole
Brexpiprazole oral tablets.
Other Names:
  • OPC-34712
  • OPC-331
Drug: Sertraline
Sertraline oral capsules.
Other Names:
  • Zoloft
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
Experimental: Brexpiprazole
Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.
Drug: Brexpiprazole
Brexpiprazole oral tablets.
Other Names:
  • OPC-34712
  • OPC-331
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
Active Comparator: Sertraline
Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.
Drug: Sertraline
Sertraline oral capsules.
Other Names:
  • Zoloft
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
Drug: Brexpiprazole Matching Placebo
Brexpiprazole matching placebo oral tablets.
Placebo Comparator: Placebo
Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
Drug: Brexpiprazole Matching Placebo
Brexpiprazole matching placebo oral tablets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, Week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 331-201-00061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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