Clinical trial NCT05189977: 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
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2022-01-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: 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
timeFrame: 21 days
measure: 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.
timeFrame: 21 days
measure: 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.
timeFrame: 21 days
measure: 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.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: For additional information regarding sites (California, Texas, New Jersey, Minnesota)
state: New Jersey
Study officials:
References: