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Prevention of Posttraumatic Stress Disorder (PTSD) With Early Hydrocortisone Treatment: Pilot

NCT00597857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2009-01-28

No results posted yet for this study

Summary

People experience a wide range of outcomes following a traumatic event. Although rates differ depending on type of trauma, 20-60% of trauma victims may develop posttraumatic stress disorder (PTSD). However, not all trauma victims develop PTSD. Previous research has found that trauma victims who develop PTSD excrete lower levels of urinary cortisol immediately after a trauma than victims who do not develop PTSD. Other research has suggested that increasing levels of cortisol may protect against the development of PTSD in patients such as yourself- but this has not yet been examined. Cortisol is a naturally occurring hormone in your body, and the present study is designed to test whether increasing cortisol levels can protect against or decrease symptoms of PTSD. Participants in this study will be randomly assigned to one of two treatment groups. Participants will receive either hydrocortisone (20mg, twice per day) or a placebo (a sugar pill) for 10 days with a six-day taper. There is an equal chance of being in either treatment group, and neither the participant nor the experimenters will know which treatment was received (except in case of an emergency).

Conditions

Interventions

DRUG

Hydrocortisone

Participants will receive a tapering low-dose of hydrocortisone in pill form for 10 days, twice a day, after the trauma.

DRUG

placebo

receipt of a placebo pill for 16 days

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Kent State University

    lead OTHER

Principal Investigators

  • Doulas L Delahanty, PhD · Kent State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-08-31
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597857 on ClinicalTrials.gov