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

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ClinicalTrials.gov Identifier: NCT00597857
Recruitment Status : Unknown
Verified January 2009 by Kent State University.
Recruitment status was:  Recruiting
First Posted : January 18, 2008
Last Update Posted : January 28, 2009
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Kent State University

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).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Hydrocortisone Drug: placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of PTSD With Early Hydrocortisone Treatment: Pilot
Study Start Date : June 2005
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : November 2009


Arm Intervention/treatment
Placebo Comparator: 1
receipt of a placebo pill for 16 days
Drug: placebo
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).
Drug: Hydrocortisone
Participants will receive a tapering low-dose of hydrocortisone in pill form for 10 days, twice a day, after the trauma.
Other Names:
  • Cortisol
  • Cortef
  • Hydrocortone




Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale (CAPS) [ Time Frame: one- and three-months post-trauma ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597857


Contacts
Contact: Douglas L Delahanty, PhD (330) 672-2395 ddelahan@kent.edu

Locations
United States, Ohio
Akron City Hospital Recruiting
Akron,, Ohio, United States, 44309
Contact: William Wallon, MD    330-971-1721    FallonW@summa-health.org   
Sub-Investigator: William Fallon, MD         
Sponsors and Collaborators
Kent State University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Doulas L Delahanty, PhD Kent State University

Publications:
Delahanty, D.L., Royer, D.K., Spoonster, E., & Raimonde, A.J. (2003). Peritraumatic dissociation is inversely related to catecholamine levels in initial urine samples of motor vehicle accident victims. Journal of Trauma and Dissociation, 4, 65-80.

Responsible Party: Douglas L. Delahanty, PhD, Kent State University
ClinicalTrials.gov Identifier: NCT00597857     History of Changes
Other Study ID Numbers: 05-025
R34MH073014 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents