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A Phase 3 Trial of Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

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ClinicalTrials.gov Identifier: NCT04124614
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult subjects with Post-Traumatic Stress Disorder.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Brexpiprazole Drug: Sertraline Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Estimated Study Start Date : October 23, 2019
Estimated Primary Completion Date : November 2, 2021
Estimated Study Completion Date : November 2, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole + Sertraline
3 pills: Dose of up to 3 mg /day may be administered of brexpiprazole, dose up to 150 mg/day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
Drug: Brexpiprazole
Up to 3 mg pill
Other Name: Rexulti

Drug: Sertraline
Up to 150 mg pill
Other Name: Zoloft

Experimental: Sertraline
3 pills: Dose up to 150 mg/ day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
Drug: Sertraline
Up to 150 mg pill
Other Name: Zoloft

Other: Placebo
Pill

Placebo
3 pills: Brexpiprazole-matched placebo tablets and Sertraline-matched placebo tablets may be administered. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
Other: Placebo
Pill




Primary Outcome Measures :
  1. Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score [ Time Frame: Up to 12 weeks ]
    CAPS-5 is a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).


Secondary Outcome Measures :
  1. Change in Clinical Global Impression - Severity (CGI-S) score [ Time Frame: Up to 12 weeks ]
    An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome. Change from baseline to assess efficacy

  2. Change in Brief Inventory or Psychosocial Functions (B-IPF) score [ Time Frame: Up to 12 weeks ]
    Patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function, with a lower score representing a worse outcome.



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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
Criteria

Inclusion Criteria:

  • Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
  • Subjects who have PTSD, diagnosed according to DSM-5, and confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.

Exclusion Criteria:

  • The index traumatic event that led to the develop of PTSD took place > 9 years before screening.
  • The index traumatic event occurred before age 16.
  • Subjects who have experienced a traumatic event within 3 months of screening.
  • Subjects who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

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 ClinicalTrials.gov identifier (NCT number): NCT04124614


Locations
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United States, California
Clinical Innovations, Inc. DBA Citrials Recruiting
Bellflower, California, United States, 90706
Contact: Carol Anduiza    562-748-4999    carol.anduiza@citrials.com   
Artemis Institute for Clinical Research Recruiting
San Diego, California, United States, 92103
Contact: Sarah Mireles    858-278-3647    smireles@artemis-research.com   
United States, New York
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
Contact: Sarah Northrup    585-241-9670    snorthrup@flclinical.com   
United States, Texas
Grayline Research Center Recruiting
Wichita Falls, Texas, United States, 76309
Contact: Jennifer Sharer    940-322-1131    jsharer@graylinecdt.com   
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT04124614     History of Changes
Other Study ID Numbers: 331-201-00071
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Sertraline
Brexpiprazole
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