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

January 23, 2017 updated by: H. Lundbeck A/S

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

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

Study Overview

Status

Status

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

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.

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.
417

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 3

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

  • Estonia
      • Tallinn, Estonia
        • EE001
  • Finland
      • Helsinki, Finland
        • FI002
      • Helsinki, Finland
        • FI003
      • Kuopio, Finland
        • FI001
      • Oulu, Finland
        • FI006
      • Tampere, Finland
        • FI005
      • Turku, Finland
        • FI004
  • France
      • Fort de France, France
        • FR002
      • Laxou, France
        • FR003
      • Nimes Cedex 9, France
        • FR004
      • Thuir Cedex, France
        • FR005
      • Tours Cedex 9, France
        • FR001
  • Italy
      • Andria, Italy
        • IT005
      • Catania, Italy
        • IT004
      • Lecce, Italy
        • IT003
      • Pisa, Italy
        • IT001
      • Siena, Italy
        • IT002
  • Poland
      • Bialystok, Poland
        • PL003
      • Gdansk, Poland
        • PL005
      • Gdansk, Poland
        • PL004
      • Leszno, Poland
        • PL001
      • Lublin, Poland
        • PL002
  • Serbia
      • Belgrade, Serbia
        • RS006
      • Nis, Serbia
        • RS004
      • Novi Knezevac, Serbia
        • RS005
  • South Africa
      • Bloemfontein, South Africa
        • ZA006
      • Cape Town, South Africa
        • ZA002
      • Cape Town, South Africa
        • ZA003
      • Cape Town, South Africa
        • ZA004
      • Cape Town, South Africa
        • ZA005
      • Durban, South Africa
        • ZA008
      • Port Elizabeth, South Africa
        • ZA007
      • Pretoria, South Africa
        • ZA001
      • Pretoria, South Africa
        • ZA009
  • Sweden
      • Falun, Sweden
        • SE001
      • Stockholm, Sweden
        • SE002
      • Uppsala, Sweden
        • SE003
  • United States
    • California
      • Los Angeles, California, United States, 90024
        • US004
      • Los Angeles, California, United States, 90102
        • US025
      • Riverside, California, United States, 92504
        • US024
      • San Diego, California, United States, 90103
        • US015
      • San Diego, California, United States, 92123
        • US008
    • Florida
      • Bradenton, Florida, United States, 34201
        • US002
      • Gainesville, Florida, United States, 32607
        • US006
      • Jacksonville, Florida, United States, 32256
        • US016
      • North Miami, Florida, United States, 33161
        • US020
      • Tampa, Florida, United States, 33609
        • US017
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • US012
    • Massachusetts
      • Roslindale, Massachusetts, United States, 02131
        • US021
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • US019
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • US007
    • New York
      • Bronx, New York, United States, 10467
        • US001
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • US009
      • Dayton, Ohio, United States, 45417
        • US005
    • Oregon
      • Portland, Oregon, United States, 97210
        • US010
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19403
        • US014
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • US011
    • Texas
      • Austin, Texas, United States, 78731
        • US003
    • Washington
      • Seattle, Washington, United States, 98104
        • US026

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:

  • 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.

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: Double

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.
Placebo Comparator: Placebo
Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)
Drug: Placebo
Once daily, tablets, orally
Experimental: Brexpiprazole
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.
Drug: Brexpiprazole
1 to 3 mg/day, once daily dose, tablets, orally

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
PTSD Symptoms Using CAPS-2 Total Score
Time Frame: Period 2: Baseline to Week 12 (of randomized period)
Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.
Period 2: Baseline to Week 12 (of randomized period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Clinical Impression Severity of Illness (CGI-S) Score
Time Frame: Period 2: Baseline to Week 12 (of randomized period)
Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Period 2: Baseline to Week 12 (of randomized period)

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.
H. Lundbeck A/S

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.
Otsuka Pharmaceutical Co., Ltd.

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

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.
December 1, 2013

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.
October 1, 2015

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.
October 1, 2015

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).
November 13, 2013

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.
November 19, 2013

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.
November 20, 2013

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.
March 13, 2017

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.
January 23, 2017

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.
January 1, 2017

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.
  • 14865A
  • 2012-004982-41 (EudraCT Number)

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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