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



Status:Terminated
Conditions:Psychiatric, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:December 2013
End Date:October 2015

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Trial Summary
Trial Overview
Inclusion Criteria

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 or
sertraline on PTSD symptoms.


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 pre-defined Clinician-Administered PTSD Scale Part 2 (CAPS-2) total
score 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.
We found this trial at
23
sites
US001
Bronx, New York 10467
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Bronx, NY
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US003
Austin, Texas 78731
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Austin, TX
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US002
Bradenton, Florida 34201
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Bradenton, FL
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US009
Cincinnati, Ohio 45219
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Cincinnati, OH
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US005
Dayton, Ohio 45417
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Dayton, OH
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US006
Gainesville, Florida 32607
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Gainesville, FL
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US012
Indianapolis, Indiana 46260
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Indianapolis, IN
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US016
Jacksonville, Florida 32256
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Jacksonville, FL
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US019
Las Vegas, Nevada 89102
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Las Vegas, NV
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US004
Los Angeles, California 90024
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Los Angeles, CA
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US025
Los Angeles, California 90102
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Los Angeles, CA
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US011
Memphis, Tennessee 38119
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Memphis, TN
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US007
Nashua, New Hampshire 03060
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Nashua, NH
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US014
Norristown, Pennsylvania 19403
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Norristown, PA
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US020
North Miami, Florida 33161
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North Miami, FL
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US010
Portland, Oregon 97210
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Portland, OR
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US024
Riverside, California 92504
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Riverside, CA
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US021
21 Roslindale Avenue
Roslindale, Massachusetts 02131
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Roslindale, MA
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US008
San Diego, California 92123
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San Diego, CA
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US015
San Diego, California 90103
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San Diego, CA
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US026
Seattle, Washington 98104
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Seattle, WA
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EE001
Tallinn,
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Tallinn,
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US017
Tampa, Florida 33609
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Tampa, FL
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