A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

Study Identifier:
331-201-00246
ClinicalTrials.gov Identifier:
NCT05189977
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Terminated/Withdrawn
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Study Details

Medical Condition
  • PTSD
Study Drug
  • Drug: Propranolol
  • Drug: Prazosin
Date
Sep 2022 - Aug 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
  • Inclusion Criteria:
  • Primary Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition criteria Diagnosis of Major Depressive Disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder, social anxiety disorder or obsessive-compulsive disorder
  • Must be able to receive a sertraline dose of 150 mg/day by the second screening visit (Day -15)
  • Exclusion Criteria
  • Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study
  • Diagnosed hypertension (including treated or untreated hypertension), or orthostatic hypotension
  • Epilepsy or a history of seizures
  • History of neuroleptic malignant syndrome or serotonin syndrome.
  • Primary DSM-5 diagnosis of Schizophrenia spectrum and other psychotic disorders, Bipolar and related disorders, Feeding and eating disorders (including anorexia nervosa or bulimia), Neurocognitive disorders (including but not limited to delirium, major or mild neurocognitive disorder due to Alzheimer's, Parkinson's, or traumatic brain injury)
  • A significant risk of committing violent acts, serious self-harm, or suicide
  • History of diabetes mellitus (type 1 or type 2)
  • Subjects with any previous exposure to brexpiprazole, or subjects with chronic use of prazosin or propranolol in the 90 days prior to the screening visit or any use in the 21 days (3 weeks) prior to the screening visit.

Protocol Summary

A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

Study Locations

Location
Status
Location
For additional information regarding sites (California, Texas, New Jersey, Minnesota)
Princeton, New Jersey, United States, 08540
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Inclusion Criteria:
  • Primary Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition criteria Diagnosis of Major Depressive Disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder, social anxiety disorder or obsessive-compulsive disorder
  • Must be able to receive a sertraline dose of 150 mg/day by the second screening visit (Day -15)
  • Exclusion Criteria
  • Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study
  • Diagnosed hypertension (including treated or untreated hypertension), or orthostatic hypotension
  • Epilepsy or a history of seizures
  • History of neuroleptic malignant syndrome or serotonin syndrome.
  • Primary DSM-5 diagnosis of Schizophrenia spectrum and other psychotic disorders, Bipolar and related disorders, Feeding and eating disorders (including anorexia nervosa or bulimia), Neurocognitive disorders (including but not limited to delirium, major or mild neurocognitive disorder due to Alzheimer's, Parkinson's, or traumatic brain injury)
  • A significant risk of committing violent acts, serious self-harm, or suicide
  • History of diabetes mellitus (type 1 or type 2)
  • Subjects with any previous exposure to brexpiprazole, or subjects with chronic use of prazosin or propranolol in the 90 days prior to the screening visit or any use in the 21 days (3 weeks) prior to the screening visit.

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