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

  • STATUS
    Recruiting
  • days left to enroll
    48
  • participants needed
    18
  • sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
Updated on 26 March 2022
sertraline
prazosin
propranolol

Summary

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

Details
Condition Post-traumatic Stress Disorder (PTSD)
Treatment Propranolol / Prazosin
Clinical Study IdentifierNCT05189977
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Primary Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition criteria Diagnosis of Major Depressive Disorder
Currently receiving sertraline for at least 90 days and maintained on stable sertraline doses of ≥100 mg/day for at least 30 days at the time of Screening

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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