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

NCT05189977 | Terminated Phase 1 FDA Drug

• 1 other identifier: 331-201-00246
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

Major Depressive Disorder (MDD); Post-traumatic stress disorder (PTSD); Generalized Anxiety Disorder (GAD); Panic Disorder; Social Anxiety Disorder (SAD); Obsessive-Compulsive Disorder (OCD); Mental disorders

Outcome Measures

Primary Outcomes (4)

• Changes between the control and treatment periods on Day 19 vs. Day 1, Day 20 vs. Day 2, and Day 21 vs. Day 3, with prazosin or propanolol in the presence of brexpiprazole + sertraline or sertraline alone at steady state

  Mean difference in baseline-adjusted change in systolic blood pressure (ΔΔSBP), measured in mmHg, from supine to standing positions will be assessed.

  21 days

• Maximum change in SBP, measured in mmHg, from supine to standing position in the presence of brexpiprazole + sertraline or sertraline alone at steady state will be assessed.

  21 days

• Maximum change in diastolic blood pressure (DBP), measured in mmHg, from supine to standing position in the presence of brexpiprazole + sertraline or sertraline alone at steady state will be assessed.

  21 days

• Maximum change in resting heart rate (HR), measured in beats per minute (bpm), from supine to standing position will be assessed in the presence of brexpiprazole + sertraline or sertraline alone at steady state will be assessed.

  21 days

Study Arms (2)

Sertraline alone at steady state

ACTIVE COMPARATOR

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.

Drug: Propranolol; Drug: Prazosin

Sertraline + brexpiprazole at steady state

ACTIVE COMPARATOR

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.

Drug: Propranolol; Drug: Prazosin

Interventions

Propranolol 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.

Sertraline + brexpiprazole at steady state; Sertraline alone at steady state

Prazosin 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; Sertraline alone at steady state

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (1)

For additional information regarding sites (California, Texas, New Jersey, Minnesota)

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Generalized Anxiety Disorder; Panic Disorder; Phobia, Social; Obsessive-Compulsive Disorder; Mental Disorders

Interventions

Propranolol; Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Depressive Disorder; Mood Disorders; Anxiety Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: • Open: no masking is used. All involved know the identity of the intervention assignment.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: • 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

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: January 13, 2022
• Study Start: September 7, 2022
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

US (1)