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

Primary Purpose

Post-traumatic Stress Disorder, PTSD

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Brexpiprazole
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US004
  • US025
  • US024
  • US015
  • US008
  • US002
  • US006
  • US016
  • US020
  • US017
  • US012
  • US021
  • US019
  • US007
  • US001
  • US009
  • US005
  • US010
  • US014
  • US011
  • US003
  • US026
  • EE001
  • FI002
  • FI003
  • FI001
  • FI006
  • FI005
  • FI004
  • FR002
  • FR003
  • FR004
  • FR005
  • FR001
  • IT005
  • IT004
  • IT003
  • IT001
  • IT002
  • PL003
  • PL004
  • PL005
  • PL001
  • PL002
  • RS006
  • RS004
  • RS005
  • ZA006
  • ZA002
  • ZA003
  • ZA004
  • ZA005
  • ZA008
  • ZA007
  • ZA001
  • ZA009
  • SE001
  • SE002
  • SE003

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Brexpiprazole

Arm Description

Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)

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.

Outcomes

Primary Outcome Measures

PTSD Symptoms Using CAPS-2 Total Score
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.

Secondary Outcome Measures

Global Clinical Impression Severity of Illness (CGI-S) Score
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).

Full Information

First Posted
November 13, 2013
Last Updated
January 23, 2017
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01987960
Brief Title
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)
Arm Title
Brexpiprazole
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily, tablets, orally
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
1 to 3 mg/day, once daily dose, tablets, orally
Primary Outcome Measure Information:
Title
PTSD Symptoms Using CAPS-2 Total Score
Description
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.
Time Frame
Period 2: Baseline to Week 12 (of randomized period)
Secondary Outcome Measure Information:
Title
Global Clinical Impression Severity of Illness (CGI-S) Score
Description
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).
Time Frame
Period 2: Baseline to Week 12 (of randomized period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US004
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
US025
City
Los Angeles
State/Province
California
ZIP/Postal Code
90102
Country
United States
Facility Name
US024
City
Riverside
State/Province
California
ZIP/Postal Code
92504
Country
United States
Facility Name
US015
City
San Diego
State/Province
California
ZIP/Postal Code
90103
Country
United States
Facility Name
US008
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
US002
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
US006
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
US016
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
US020
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
US017
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
US012
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
US021
City
Roslindale
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
US019
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
US007
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
US001
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
US009
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
US005
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
US010
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
US014
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
US011
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
US003
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
US026
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
EE001
City
Tallinn
Country
Estonia
Facility Name
FI002
City
Helsinki
Country
Finland
Facility Name
FI003
City
Helsinki
Country
Finland
Facility Name
FI001
City
Kuopio
Country
Finland
Facility Name
FI006
City
Oulu
Country
Finland
Facility Name
FI005
City
Tampere
Country
Finland
Facility Name
FI004
City
Turku
Country
Finland
Facility Name
FR002
City
Fort de France
Country
France
Facility Name
FR003
City
Laxou
Country
France
Facility Name
FR004
City
Nimes Cedex 9
Country
France
Facility Name
FR005
City
Thuir Cedex
Country
France
Facility Name
FR001
City
Tours Cedex 9
Country
France
Facility Name
IT005
City
Andria
Country
Italy
Facility Name
IT004
City
Catania
Country
Italy
Facility Name
IT003
City
Lecce
Country
Italy
Facility Name
IT001
City
Pisa
Country
Italy
Facility Name
IT002
City
Siena
Country
Italy
Facility Name
PL003
City
Bialystok
Country
Poland
Facility Name
PL004
City
Gdansk
Country
Poland
Facility Name
PL005
City
Gdansk
Country
Poland
Facility Name
PL001
City
Leszno
Country
Poland
Facility Name
PL002
City
Lublin
Country
Poland
Facility Name
RS006
City
Belgrade
Country
Serbia
Facility Name
RS004
City
Nis
Country
Serbia
Facility Name
RS005
City
Novi Knezevac
Country
Serbia
Facility Name
ZA006
City
Bloemfontein
Country
South Africa
Facility Name
ZA002
City
Cape Town
Country
South Africa
Facility Name
ZA003
City
Cape Town
Country
South Africa
Facility Name
ZA004
City
Cape Town
Country
South Africa
Facility Name
ZA005
City
Cape Town
Country
South Africa
Facility Name
ZA008
City
Durban
Country
South Africa
Facility Name
ZA007
City
Port Elizabeth
Country
South Africa
Facility Name
ZA001
City
Pretoria
Country
South Africa
Facility Name
ZA009
City
Pretoria
Country
South Africa
Facility Name
SE001
City
Falun
Country
Sweden
Facility Name
SE002
City
Stockholm
Country
Sweden
Facility Name
SE003
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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