What side effects are associated with this type of intervention?

Common treatments for PTSD, such as glucocorticoids and SSRIs/SNRIs, have several known side effects. Glucocorticoids like hydrocortisone can lead to hyperglycemia, increased infection risk, bone loss, fractures, and neuropsychiatric issues. SSRIs and SNRIs may cause nausea, insomnia, sexual dysfunction, and increased bleeding risk. Both treatment types are effective in reducing PTSD symptoms but require careful monitoring for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms by altering neurotransmitter levels in the brain. While hydrocortisone and other glucocorticoids have shown potential in clinical trials for reducing PTSD symptoms by mimicking cortisol and enhancing stress recovery, they are not yet FDA-approved specifically for PTSD treatment. Current research continues to explore their efficacy and safety in this context.

What other types of research exist?

Promising novel alternatives to hydrocortisone for PTSD treatment include: 1) JAK inhibitors, which have shown potential in modulating immune response and inflammation; 2) Cannabinoids, which have demonstrated some efficacy in reducing anxiety and stress-related symptoms; and 3) Acupuncture/acupressure, which may offer modest benefits in stress reduction. These alternatives are still under investigation and should be discussed with a healthcare provider.

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Corticosteroid

Hydrocortisone for Preventing PTSD

Phase 2

Recruiting

Led By Rachel Yehuda, PhD

Research Sponsored by Rachel Yehuda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight: 99 lb - 242 lbs

Experienced a traumatic event less than 6 hours ago

Must not have

Individuals prescribed a narcotic medication to alleviate acute pain in the ED will not be eligible to participate in the treatment study.

Currently taking oral steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months

Awards & highlights

Summary

This trial tests whether a single dose of hydrocortisone (HCORT) can prevent PTSD in highly distressed trauma survivors. HCORT works by boosting the body's natural stress recovery system. If successful, this could provide a simple, portable treatment for those at high risk of PTSD.

Who is the study for?

This trial is for adults who've recently experienced trauma, feel highly distressed or disconnected, and have a heart rate of 80 bpm or more. They must weigh between 99-242 lbs and not be severely injured, intoxicated, pregnant, on steroids or benzodiazepines, nor have certain chronic diseases or mental health conditions.

What is being tested?

The study tests if a single dose of hydrocortisone (HCORT), given within six hours after trauma can prevent PTSD compared to a placebo. It's randomized with assessments at multiple intervals post-treatment to measure the decline in PTSD symptoms and related mental health issues.

What are the potential side effects?

Potential side effects are not detailed but may include those typical of corticosteroids like mood swings, increased blood pressure, sleep problems, weight gain, and elevated blood sugar levels.

Eligibility Criteria

Inclusion Criteria

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

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My weight is between 99 and 242 lbs.

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I experienced a traumatic event within the last 6 hours.

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I am 18 years old or older.

Exclusion Criteria

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

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I have not been prescribed narcotics for acute pain in the emergency department.

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I am currently taking oral steroids.

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I am able to understand and agree to the study's procedures.

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I have a severe injury or condition that needed surgery under general anesthesia.

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My weight is between 99 lbs and 242 lbs.

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I do not have conditions like unstable diabetes, heart failure, or active infections.

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I have not taken benzodiazepines since experiencing trauma.

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I lost consciousness for more than 30 minutes due to a recent severe head injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinician Administered PTSD Scale (CAPS)

Secondary study objectives

Change in The Clinical Global Impression - Severity (CGI-S)

Change in the Clinical Global Impression - Improvement (CGI-I)

Montgomery-Asberg Depression Rating Scale (MADRS)

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: HCORTActive Control1 Intervention

180 mg capsule PO

Group II: PlaceboPlacebo Group1 Intervention

matching capsule PO

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Traumatic Stress Disorder (PTSD) work by targeting different aspects of the body's stress response. Hydrocortisone, for example, mimics cortisol, a hormone that helps the body recover from stress, potentially reducing PTSD symptoms and promoting resilience. SSRIs and SNRIs increase serotonin and norepinephrine levels in the brain, which can improve mood and reduce anxiety. Prazosin, an alpha-adrenergic receptor blocker, helps reduce nightmares and improve sleep by blocking adrenaline's effects. Understanding these mechanisms is important for PTSD patients as it allows for more personalized and effective treatment strategies.