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

Sponsor ID
331-201-00246
Clinicaltrials.gov ID
NCT05189977
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Terminated/Withdrawn
Sponsor ID
331-201-00246
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • PTSD
    • Sex
    Female & Male
    Trial Dates
    Sep 2022 - Aug 2023
    Healthy Volunteers
    No
    • 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.

    Study Summary

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

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: Propranolol
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    34
    Additional Study Details

    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

    Exclusion Criteria

    Inclusion and Exclusion 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.

    Locations

    Location
    Status
    Location
    For additional information regarding sites (California, Texas, New Jersey, Minnesota)
    Princeton, New Jersey, United States, 08540
    Status
    N/A

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