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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03033069
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : October 21, 2019
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Drug: Brexpiprazole (OPC-34712) Drug: Sertraline Other: Placebo Phase 2

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 subjects with PTSD.

This study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder
Actual Study Start Date : January 2017
Actual Primary Completion Date : November 8, 2018
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Brexpiprazole Monotherapy
Flexible dose
Drug: Brexpiprazole (OPC-34712)
Active Comparator: Brexpiprazole & Zoloft (sertaline) Combination Therapy
Flexible dose
Drug: Brexpiprazole (OPC-34712)
Drug: Sertraline
Other Name: Zoloft

Active Comparator: Zoloft (setraline) monotherapy
Flexible dose
Drug: Sertraline
Other Name: Zoloft

Placebo Comparator: Placebo
Other: Placebo

Primary Outcome Measures :
  1. Mean change in baseline of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score [ Time Frame: Baseline - Week 12 ]
    CAPS-5 is a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by the DSM-5.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and Female subjects 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03033069

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

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT03033069     History of Changes
Other Study ID Numbers: 331-201-00061
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents