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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-07

Study Completion Date

2023-08-03

Brief Summary

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

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Detailed Description

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Conditions

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Post-traumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

• Cross-over: participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

• Open: no masking is used. All involved know the identity of the intervention assignment.

Study Groups

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Sertraline alone at steady state

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.

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Propranolol (tablet, oral ): 40 mg QD Day 3 and Day 21

Intervention 1 is a single dose of prazosin administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.

Prazosin

Intervention Type DRUG

Prazosin (tablet, oral): 1 mg QD Day 2 and Day 20

Intervention 2 is a single dose of propranolol administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.

Sertraline + brexpiprazole at steady state

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.

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Propranolol (tablet, oral ): 40 mg QD Day 3 and Day 21

Intervention 1 is a single dose of prazosin administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.

Prazosin

Intervention Type DRUG

Prazosin (tablet, oral): 1 mg QD Day 2 and Day 20

Intervention 2 is a single dose of propranolol administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.

Interventions

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Propranolol

Propranolol (tablet, oral ): 40 mg QD Day 3 and Day 21

Intervention 1 is a single dose of prazosin administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.

Intervention Type DRUG

Prazosin

Prazosin (tablet, oral): 1 mg QD Day 2 and Day 20

Intervention 2 is a single dose of propranolol administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No