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

Primary Purpose

Post-traumatic Stress Disorder (PTSD)

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Prazosin
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-traumatic Stress Disorder (PTSD) focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sertraline alone at steady state

Sertraline + brexpiprazole at steady state

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 22, 2021
Last Updated
July 28, 2022
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Iqvia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05189977
Brief Title
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
Official Title
A Phase 1, Open-label, Fixed-sequence, Cross-over Trial to Assess the Effects of a Single Dose of Prazosin or Propranolol in the Presence of Brexpiprazole/Sertraline at Steady-state on Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
• 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
Masking
None (Open Label)
Masking Description
• Open: no masking is used. All involved know the identity of the intervention assignment.
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sertraline alone at steady state
Arm Type
Active Comparator
Arm 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.
Arm Title
Sertraline + brexpiprazole at steady state
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
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
Intervention Name(s)
Prazosin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Mean difference in baseline-adjusted change in systolic blood pressure (ΔΔSBP), measured in mmHg, from supine to standing positions will be assessed.
Time Frame
21 days
Title
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.
Time Frame
21 days
Title
Maximum change in DBP, measured in mmHg, from supine to standing position in the presence of brexpiprazole + sertraline or sertraline alone at steady state will be assessed.
Time Frame
21 days
Title
Maximum change in resting 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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
OPDC Call Center
Phone
844-687-8522
Email
OtsukaRMReconciliation@rmpdc.org
Facility Information:
Facility Name
For additional information regarding sites (California, Texas, New Jersey, Minnesota)
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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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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