Recruiting

Hydrocortisone

Sponsor:

Kent State University

Code:

NCT00597857

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hydrocortisone

placebo

Study Details

Brief 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

Posttraumatic Stress Disorder

Study ID

NCT00597857

Start date

Jun, 2005

Status verified date

Jan, 2009

Completion date

Nov, 2009

Anticipated

Primary completion date

Aug, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • involved in a traumatic event and admitted to the level 1 trauma center within 12 hours after the trauma

Exclusion Criteria:

  • Glasgow coma scale score of less than 14 (at the time that you speak to patient)
  • Amnestic for the events during and immediately following the traumatic event
  • Unable to understand consent procedure or current substance abuse
  • Traumatic event occurred more than 12 hours before initial medication dose can be given (i.e., patient life-flight or transferred after significant time has passed).
  • Allergy to cortisol.
  • Pregnant or breast-feeding
  • Traumatic event of potentially ongoing nature that the participant is likely to be re-exposed to during the study (e.g. domestic violence)
  • Presence of injuries (e.g. pelvic or lower extremity fractures) requiring readmission for surgery 1-2 weeks later once swelling has diminished. Patients requiring such delayed operative procedures will be excluded.
  • Presence of medical condition that contraindicates the administration of cortisol, including (but not necessarily limited to) peptic ulcers, Cushing's disease, hypothyroidism, current alcoholism or cirrhosis, hepatitis, diverticulitis, nonspecific ulcerative colitis, myasthenia gravis, seizure disorders, renal insufficiency, disorders of immunosuppression, current viral or bacterial infection, diabetes mellitus, history of myocardial infarction, or recipient of solid organ or bone marrow transplant.
  • On a current corticosteroid regimen (inhaled, oral, or injection). This may include patients with asthma, multiple sclerosis, arthritis, allergic conditions, optic neuritis, or tuberculosis
  • Corticosteroid use in the previous 6 months
  • Current use of medications that may have potentially dangerous interactions with cortisol including other corticosteroids, any immunosuppressant medications, drugs affecting hepatic microsomal enzymes, cyclosporine, and anticholinesterase agents.
  • Injuries requiring treatment with steroids (e.g., suspected spinal cord injury, cerebral edema).
  • Patients must be able to take oral medications within 12 hours post-trauma.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: 1

receipt of a placebo pill for 16 days

active comparator: 2

oral pill of hydrocortisone (ranging from 20mg - 2.5mg) taken for 10 days with a taper for 6 days (based on Pitman et al, 2002).

Interventions

Hydrocortisone

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

placebo

receipt of a placebo pill for 16 days

Primary outcome measure

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: one- and three-months post-trauma ]

Central Contacts and Locations

Central contacts

Douglas L Delahanty, PhD

(330) 672-2395ddelahan@kent.edu

Locations

Akron City Hospital

Recruiting

Akron,, Ohio, United States, 44309

Contacts

William Wallon, MD

330-971-1721FallonW@summa-health.org

More Information

Sponsor

Kent State University

Last update posted

Jan 28, 2009

Last verified

Jan, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kent State University on 2009-01-28.