Prazosin for Post-Traumatic Stress Disorder

(ATLAS Trial)

KJ
CL
Overseen ByCarolyn L Fort, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how prazosin, a medication that may alleviate PTSD symptoms, affects the body's sugar processing. Researchers aim to determine if prazosin can reduce risks such as insulin resistance, which can lead to diabetes, and if it impacts depression in individuals with PTSD. The trial focuses on Veterans with PTSD who do not have diabetes and are not currently using certain medications. Participants will contribute to uncovering potential new treatments for PTSD-related health issues. As a Phase 4 trial, prazosin is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

What is the safety track record for prazosin?

Research has shown that prazosin has been safely used in people for a long time. The FDA has approved it to treat high blood pressure, and it has been studied for its effects on PTSD symptoms. In earlier studies, most patients tolerated prazosin well. Side effects were usually minor, such as dizziness or fatigue, and serious problems were rare. Since this study is in a later stage, prazosin has already passed initial safety tests. This suggests it is considered safe enough for further research on its potential benefits for PTSD and insulin resistance.12345

Why are researchers enthusiastic about this study treatment?

Prazosin is unique because it offers a different approach to treating Post-Traumatic Stress Disorder (PTSD) compared to the standard options like SSRIs or SNRIs. Most PTSD treatments work by altering serotonin or norepinephrine levels, but prazosin targets the alpha-1 adrenergic receptors, which can help reduce nightmares and sleep disturbances associated with PTSD. Researchers are excited about prazosin because it addresses specific symptoms of PTSD, potentially improving sleep quality and overall mental health for patients with fewer side effects.

What evidence suggests that prazosin might be an effective treatment for PTSD?

Studies have shown that prazosin can help reduce upsetting dreams and improve sleep in people with PTSD. It significantly improves overall PTSD symptoms, especially nightmares and sleep problems. In this trial, participants will receive prazosin to assess its impact on mental health and metabolic measures. Some research suggests that prazosin works better when combined with other medications like benzodiazepines, enhancing its benefits for sleep issues and PTSD severity. However, results are mixed; some studies show it performs similarly to a placebo. Overall, prazosin might help with certain PTSD symptoms, particularly those related to sleep, but its effectiveness can vary.678910

Who Is on the Research Team?

KJ

Katharine J Liang, MD PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for Veterans diagnosed with PTSD. It aims to include those who may have or be at risk for insulin resistance or metabolic syndrome. People with certain medical conditions, medications, or other factors that could interfere with the study may not be eligible.

Inclusion Criteria

Veteran of the US military
I have been diagnosed with PTSD based on a clinical assessment.

Exclusion Criteria

History of moderate or severe Traumatic Brain Injury (TBI) as defined by Ohio State University TBI Identification Method
Pregnancy, lactation, or anticipated pregnancy during study participation
Increased risk of suicide necessitating inpatient treatment, intensive outpatient care, or treatment excluded by protocol
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prazosin to assess its effect on insulin sensitivity and mental health symptoms

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • prazosin

Trial Overview

The study tests whether prazosin—a medication sometimes used for PTSD—can also help improve how the body handles sugar (insulin sensitivity) in people with PTSD. Researchers will monitor changes in both mental health and metabolism.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: PrazosinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Using Prazosin to Treat Posttraumatic Stress Disorder and ...

Prazosin was significantly more effective than placebo in reducing distressing dreams in PTSD patients, although our results should be interpreted with caution ...

Trial of Prazosin for Post-Traumatic Stress Disorder in ...

There are limited data on the ability of prazosin to have sustained efficacy for chronic PTSD symptoms over longer periods.

Prazosin 3 Times Daily for PTSD-Induced Psychological ...

Data regarding the overall effectiveness of prazosin for PTSD have been inconsistent.5–7 While prazosin is typically dosed at night for PTSD ...

Factors impacting prazosin efficacy for nightmares and ...

Prazosin improves insomnia and nightmares in PTSD patients. · Benzodiazepines enhance prazosin's efficacy for insomnia and PTSD severity.

Prazosin for PTSD-related nightmares (Guidelines)

There is no evidence that prazosin is effective as monotherapy for global PTSD symptoms and there is conflicting evidence for its efficacy on overall sleep ...

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outcomes.com

outcomes.com/

Outcomes | Healthcare Solutions for Pharmacy, Pharma, and ...

The Outcomes platform is the ideal solution for gaining insight across the entire treatment journey. Gain access to all the data you need to improve medication ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31422062/

Cardiovascular, mortality, and kidney outcomes with GLP-1 ...

We did a meta-analysis using a random-effects model to estimate overall hazard ratios (HRs) for MACE, its components, death from any cause, hospital admission ...

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secure.outcomesmtm.com

secure.outcomesmtm.com/

Outcomes

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