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

Otsuka

Status and phase: Terminated; Phase 1

Conditions: Post-traumatic Stress Disorder (PTSD)

Treatments: Drug: Prazosin; Drug: Propranolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT05189977

331-201-00246

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Sertraline alone at steady state

Active Comparator group

Description:

To assess the hemodynamic changes associated with the effects of a single dose of prazosin or propranolol in the presence of brexpiprazole + sertraline at steady state compared with a single dose of prazosin or propranolol in the presence of sertraline alone at steady state.

Treatment:

Drug: Prazosin

Drug: Propranolol

Sertraline + brexpiprazole at steady state

Active Comparator group

Description:

To assess the hemodynamic changes associated with the effects of a single dose of prazosin or propranolol in the presence of brexpiprazole + sertraline at steady state compared with a single dose of prazosin or propranolol in the presence of sertraline alone at steady state.

Treatment:

Drug: Prazosin

Drug: Propranolol