Hydrocortisone for Prevention of Post-Traumatic Stress Disorder

NCT02402114 | Withdrawn DMC

• 1 other identifier: HN4712
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after exposure to a dangerous or life-threatening event. It is characterized by persistent fear- and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt. These symptoms can interfere significantly with patients' lives and in some cases can be debilitating. One of the most frequent causes of PTSD is being a victim of a violent, interpersonal assault. PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded too strongly in a patient's long-term memory, remaining too accessible and "present" to the patient long after the actual threat has passed. In recent years evidence has emerged that it may be possible to prevent PTSD by moderating the process of memory consolidation that occurs in the hours and days after a traumatic event. Early research has suggested that enhancing the body's natural cortisol response to a stressful event may be a safe and effective way of moderating the process of memory consolidation and promoting adaptive, non-pathological memory encoding. In particular, the administration of hydrocortisone, a safe and widely used drug that mimics the body's own cortisol hormone, appears to reduce the risk of developing PTSD in patients who have sustained a traumatic event. However, this research is still in relatively early stages, and requires larger trials to confirm its efficacy. In addition, the research thus far has not adequately targeted assault victims, whom Investigator feel are some of the patients most likely to benefit from such an approach. Investigators propose a prospective, placebo-controlled, double-blinded trial of administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein Medical Center Philadelphia Emergency Department to determine if this approach has efficacy in preventing PTSD. This study is designed as a pilot study, with the hopes that the data gathered in it can be used to design a larger and more robust trial in the future.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Positive PTSD screens

  Percentage of patients that are PTSD positive on the PTSD Checklist scores (PCL-S) as per DSM-IV criteria after 6 weeks of enrollment

  6 weeks

Secondary Outcomes (3)

• Difference in PCL-S between HT group and placebo groups

  6 weeks

• Positive PTSD screens

  6 months

• Difference in PCL-S between HT group and placebo groups

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Subject randomized to this group receives 1 oral dose of Hydrocortisone 120 mg

Drug: Hydrocortisone

Placebo

PLACEBO COMPARATOR

Subject randomized to this group will receive an oral sugar/placebo pill that looks similar to the Hydrocortisone pill.

Drug: Hydrocortisone

Interventions

Hydrocortisone DRUG

120 mg Hydrocortisone given orally one time.

Also known as: Cortef

Intervention; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than age 18
• Presenting to ER for treatment of injuries sustained in a violent physical assault
• Assault met DSM-IV "A" criterion (in patient's view, the assault involved or threatened death or serious injury)
• Patient will be discharged home from Emergency Room

You may not qualify if:

• Intoxicated due to drugs, alcohol or medication at the time they are approached.
• Under arrest or in police custody at the time they are approached.
• No memory of the assault
• Cognitive impairment or psychosis identified by the treating physician or on chart review.
• Patients whose presenting injury is a result of domestic (i.e. injured by a primary caregiver or significant other) or sexual violence
• Under age 18
• Not medically stable enough to participate
• Non-English speakers
• Pregnant or nursing women
• Already on steroid treatment
• Immunosuppressed (taking immunosuppressant medication, cancer undergoing active chemotherapy, AIDS, HIV not on HAART therapy)
• Have an active infection identified by the treating physician or on chart review
• Allergy or adverse reaction to hydrocortisone or other corticosteroids
• Diabetic
• On warfarin therapy

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• James Gardner, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: February 2, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)