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Alpha-1 Adrenergic Receptor Antagonist

Prazosin for Post-Traumatic Stress Disorder (PREDICT Trial)

Phase 3
Recruiting
Led By Rebecca C. Hendrickson, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the pcl5 total score is assessed at baseline, during each stage of the study, and at the endpoint of the study. thus, measurements will be scheduled to occur at the following time points, relative to the baseline visit: 0, 4, 8, 9-12, 16, and 20 weeks
Awards & highlights

PREDICT Trial Summary

This trial is testing whether two simple tests can predict whether someone with PTSD will respond to the medication prazosin.

Who is the study for?
This trial is for U.S. veterans with PTSD who can take prazosin, are not pregnant or breastfeeding, and don't have severe psychiatric conditions like schizophrenia or bipolar type I. Participants should not be in immediate danger to themselves or others and must agree to use birth control if applicable.Check my eligibility
What is being tested?
The study tests whether blood pressure response upon standing and eye reaction to light can predict the effectiveness of prazosin for PTSD treatment. It also examines how trauma exposure affects stress-response regulation in the body.See study design
What are the potential side effects?
Prazosin may cause dizziness, especially when standing up due to lower blood pressure, as well as potential sleepiness or headaches. The placebo used for comparison should have no active effects.

PREDICT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the pcl5 total score is assessed at baseline, during each stage of the study, and at the endpoint of the study. thus, measurements will be scheduled to occur at the following time points, relative to the baseline visit: 0, 4, 8, 9-12, 16, and 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and the pcl5 total score is assessed at baseline, during each stage of the study, and at the endpoint of the study. thus, measurements will be scheduled to occur at the following time points, relative to the baseline visit: 0, 4, 8, 9-12, 16, and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in total PTSD Checklist for DSM 5 (PCL5) score

Side effects data

From 2017 Phase 4 trial • 20 Patients • NCT02199652
20%
fainting
10%
psychiatric hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Prazosin

PREDICT Trial Design

2Treatment groups
Experimental Treatment
Group I: Open label, blinded discontinuation, prazosin, placeboExperimental Treatment2 Interventions
All participants in this study will begin with 8 weeks of active treatment (prazosin), followed by a 4 week "blinded discontinuation" block where they will take a capsule that will start out as active treatment (prazosin), but will at some point change to placebo. Following these phases of the study, participants will be randomized to two arms. In this first arm, participants will spend 4 weeks on active treatment (prazosin), followed by 4 weeks on placebo.
Group II: Open label, blinded discontinuation, placebo, prazosinExperimental Treatment2 Interventions
All participants in this study will begin with 8 weeks of active treatment (prazosin), followed by a 4 week "blinded discontinuation" block where they will take a capsule that will start out as active treatment (prazosin), but will at some point change to placebo. Following these phases of the study, participants will be randomized to two arms. In this second arm, participants will spend 4 weeks on placebo, followed by 4 weeks on active treatment (prazosin).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prazosin
2010
Completed Phase 4
~1590
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,305,965 Total Patients Enrolled
Rebecca C. Hendrickson, MD PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

Media Library

Prazosin (Alpha-1 Adrenergic Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03539614 — Phase 3
Post-Traumatic Stress Disorder Research Study Groups: Open label, blinded discontinuation, prazosin, placebo, Open label, blinded discontinuation, placebo, prazosin
Post-Traumatic Stress Disorder Clinical Trial 2023: Prazosin Highlights & Side Effects. Trial Name: NCT03539614 — Phase 3
Prazosin (Alpha-1 Adrenergic Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03539614 — Phase 3

Frequently Asked Questions

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

Who meets the qualifications to participate in this research?

"The desired participants for this trial must have a diagnosis of post-traumatic stress disorder and be within the age brackets of 21 to 75. A total of 70 individuals are needed for the study."

Answered by AI

Is this clinical trial open to patients who are younger than 85 years old?

"In order to qualify for this study, patients must be aged 21-75. Out of the 488 total clinical trials taking place, 46 are specifically for minors and 342 are for adults over 65."

Answered by AI

What are Prazosin's common therapeutic benefits?

"Prazosin is a medication that is most often used to manage symptoms of post-traumatic stress disorder. Additionally, it can be effective in treating conditions such as nightmares, hypertensive disease, and benign prostatic hyperplasia."

Answered by AI

Are there other Prazosin studies that have been completed?

"There are seven ongoing clinical trials studying Prazosin. One of these live studies is in Phase 3, with the rest being conducted primarily in Seattle, Washington. In total, there are nine locations running research for this treatment."

Answered by AI

Has Prazosin undergone the FDA's drug approval process?

"Prazosin received a safety score of 3 because there is both efficacy and safety data from Phase 3 trials."

Answered by AI

What is the total number of individuals enrolled in this experiment?

"That is right, the clinicaltrials.gov website has information indicating that this trial is currently looking for subjects. The study was first advertised on 6/4/2018 and updated as recently as 4/1/2022. They are hoping to find 70 patients from 1 location."

Answered by AI

Are new enrollees still being taken in for this research project?

"Yes, this trial is currently recruiting patients. The study was first posted on June 4th, 2018 and the most recent update was April 1st, 2022."

Answered by AI
~2 spots leftby Jun 2024