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Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT04174170
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description
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Brief Summary:
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 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 Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : July 21, 2023
Estimated Study Completion Date : August 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Brexpiprazole + Sertraline
3 pills: Fixed 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: Fixed 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
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


Outcome Measures
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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 symptom severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The interview consists of 30 items, with a higher score indicating a worse outcome.


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 of Psychosocial Functions (B-IPF) score [ Time Frame: Up to 12 weeks ]
    Patient-reported questionnaire consisting of 7 questions, each scored from 0 to 6, which measure PTSD-specific psychosocial function, with a higher score representing a worse outcome.


Eligibility Criteria
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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 development 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.
Contacts and Locations
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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): NCT04174170


Contacts
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Contact: Otsuka Call Center 844-687-8522 OtsukaUS@druginfo.com

Locations
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United States, New York
For additional information regarding sites, contact 844-687-8522 Recruiting
New York, New York, United States, 10010
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT04174170    
Other Study ID Numbers: 331-201-00072
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
URL: https://clinical-trials.otsuka.com

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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