Status:
TERMINATED
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Post-traumatic Stress Disorder (PTSD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05189977
Start Date
September 7 2022
End Date
August 3 2023
Last Update
January 23 2024
Active Locations (1)
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1
For additional information regarding sites (California, Texas, New Jersey, Minnesota)
Princeton, New Jersey, United States, 08540