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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

Must not have

Psychiatric: Any known diagnosis of a primary psychotic or major neurocognitive disorder, including schizophrenia, brief psychotic disorder, or Alzheimer's or other dementia, as well as bipolar type I

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

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have a major psychiatric or neurocognitive disorder like schizophrenia or Alzheimer's.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

Study treatment Arm

Placebo

Prazosin

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1450

Placebo

1995

Completed Phase 3

~2670