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

Study Identifier:
331-201-00072
ClinicalTrials.gov Identifier:
NCT04174170
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • PTSD
Study Drug
  • Drug: Brexpiprazole
  • Drug: Sertraline
Date
Oct 2019 - Jul 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
  • Participants who have post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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.
  • Participants who have experienced a traumatic event within 3 months of screening.
  • Participants 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.

Protocol 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.

Study Locations

Location
Status
Location
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 10010
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
  • Participants who have post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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.
  • Participants who have experienced a traumatic event within 3 months of screening.
  • Participants 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.

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