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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • 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

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
Intervention / Treatment
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

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

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

H. Lundbeck A/S

Collaborators

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

December 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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