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Alpha-1 Adrenergic Receptor Antagonist

Sertraline alone at steady state for Post-Traumatic Stress Disorder

Phase 1
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Study Summary

This trial is to see if prazosin or propranolol can lower blood pressure when taken with brexpiprazole/sertraline.

Eligible Conditions
  • Post-Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
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 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.
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Sertraline alone at steady stateActive Control2 Interventions
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 II: Sertraline + brexpiprazole at steady stateActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
166,961 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,974 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of Sertraline and brexpiprazole been formally recognized by the FDA?

"The safety of Sertraline and brexpiprazole at a steady state has been judged as having low risk, earning it a score of 1. This is because this is only in the first phase of trials which limits the amount of evidence regarding its efficacy and security."

Answered by AI

Are individuals below the age of 50 being considered for participation in this experiment?

"The recruitment criteria for this medical trial necessitates that interested individuals must be over 18 and below 65."

Answered by AI

What is the current enrolment capacity for this clinical trial?

"Affirmative, the clinicaltrials.gov website reveals that this trial is open for recruitment with a start date on August 22nd 2022 and an updated version posted on July 28th of the same year. This research requires 24 participants from two distinct sites to complete enrolment."

Answered by AI

Is this experiment accepting new participants at the moment?

"Affirmative, the information hosted on clinicaltrials.gov suggests this medical trial is still open to enrolment. The initial post was made on August 22nd 2022 and has since been updated most recently in July 28th 2022. There are 24 prospective patients needed across 2 research facilities."

Answered by AI

What has Sertraline + brexpiprazole combination been shown to alleviate?

"Sertraline + brexpiprazole at steady state is typically prescribed to treat angina pectoris, but has also proven useful in combating myocardial infarction, managing post traumatic stress disorder (PTSD), and moderating the effects of adrenergic alpha-antagonists."

Answered by AI

Who would be the ideal participants for this medical trial?

"This trial is recruiting 24 adults aged 18 to 65 with moral injury. The applicants must meet the DSM-V criteria for Major Depressive Disorder, PTSD, GAD, Panic Disorders, Social anxiety Disorder or OCD and be able to tolerate a daily dose of 150mg sertraline by their second screening visit (Day -15)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
2022. "A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05189977.
~13 spots leftby Apr 2025
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