Prazosin for Post-Traumatic Stress Disorder

(PREDICT Trial)

Overseen By Rebecca C Hendrickson, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Must not be taking: Prazosin, Doxazosin, Clonidine, others

Disqualifiers: Schizophrenia, Bipolar I, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. There are a variety of treatment options for PTSD, including psychotherapy (talk therapy) options, as well as medications, such as the drug prazosin. Each of the treatment options available is effective at significantly reducing the symptoms of PTSD in some, but not all, individuals with PTSD. However, investigators are not yet able to predict in advance who is likely to respond to which of the available treatments. Neither are the investigators able to explain what changes in the brain after exposure to a traumatic stressors, and why it results in persistent symptoms of PTSD for some people, but not for others. In this study, the investigators are testing two things: First, is testing whether two simple, easy tests of how an individual's blood pressure changes with standing and how an individual's eye reacts to a pulse of light may be able to predict whether that person is likely to respond to the medication prazosin for PTSD. Second, is testing whether those who have been exposed to a traumatic stress show differences in how their body regulates the response to the stress-signal noradrenaline.

Research Team

Rebecca C. Hendrickson, MD PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Eligibility Criteria

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.

Inclusion Criteria

Veteran of the U.S. Armed Forces

I am a woman who can become pregnant and agree to use birth control or abstain from sex during the study.

I have been diagnosed with PTSD.

Exclusion Criteria

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

I haven't taken certain blood pressure or sleep medications in the last week and am willing to avoid them during the study.

Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to participant or others. Note: Nonsuicidal depression comorbid with PTSD will not be exclusionary. Participants may continue in any concurrent psychotherapy or pharmacotherapy in which they are participating, other than pharmacotherapeutic agents specifically listed above. Participants with active suicidal ideation or with depression severe enough to require psychiatric hospitalization will be excluded.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive 8 weeks of active treatment with prazosin

8 weeks

Regular visits for monitoring

Blinded Discontinuation

Participants undergo a 4-week period where treatment may switch from prazosin to placebo

4 weeks

Regular visits for monitoring

Randomized Treatment

Participants are randomized to either 4 weeks of prazosin followed by 4 weeks of placebo, or vice versa

8 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Placebo
• Prazosin

Trial Overview 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.

Participant Groups

Group I: Open label, blinded discontinuation, prazosin, placebo Experimental Treatment 2 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, prazosin Experimental Treatment 2 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).

Prazosin is already approved in United States for the following indications:

Approved in United States as Minipress for:

• Hypertension
• Benign prostatic hypertrophy
• Posttraumatic stress disorder (PTSD) nightmares and hyperarousal symptoms

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+