Prevention of Posttraumatic Stress Disorder (PTSD) With Early Hydrocortisone Treatment: Pilot - Full Text View

Sponsor:	Kent State University
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by:	Kent State University
ClinicalTrials.gov Identifier:	NCT00597857

Purpose

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	Intervention
Posttraumatic Stress Disorder	Drug: Hydrocortisone Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Prevention of PTSD With Early Hydrocortisone Treatment: Pilot

Resource links provided by NLM:

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Wounds

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone Sodium Succinate Hydrocortisone cypionate

U.S. FDA Resources

Further study details as provided by Kent State University:

Primary Outcome Measures:

Clinician-Administered PTSD Scale (CAPS) [ Time Frame: one- and three-months post-trauma ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	June 2005
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

Delahanty DL, Raimonde AJ, Spoonster E. Initial posttraumatic urinary cortisol levels predict subsequent PTSD symptoms in motor vehicle accident victims. Biol Psychiatry. 2000 Nov 1;48(9):940-7.

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.

Flesher MR, Delahanty DL, Raimonde AJ, Spoonster E. Amnesia, neuroendocrine levels and PTSD in motor vehicle accident victims. Brain Inj. 2001 Oct;15(10):879-89.

Delahanty DL, Raimonde AJ, Spoonster E, Cullado M. Injury severity, prior trauma history, urinary cortisol levels, and acute PTSD in motor vehicle accident victims. J Anxiety Disord. 2003;17(2):149-64.

Delahanty DL, Bogart LM, Figler JL. Posttraumatic stress disorder symptoms, salivary cortisol, medication adherence, and CD4 levels in HIV-positive individuals. AIDS Care. 2004 Feb;16(2):247-60.

Pitman RK, Sanders KM, Zusman RM, Healy AR, Cheema F, Lasko NB, Cahill L, Orr SP. Pilot study of secondary prevention of posttraumatic stress disorder with propranolol. Biol Psychiatry. 2002 Jan 15;51(2):189-92.

Schelling G, Kilger E, Roozendaal B, de Quervain DJ, Briegel J, Dagge A, Rothenhäusler HB, Krauseneck T, Nollert G, Kapfhammer HP. Stress doses of hydrocortisone, traumatic memories, and symptoms of posttraumatic stress disorder in patients after cardiac surgery: a randomized study. Biol Psychiatry. 2004 Mar 15;55(6):627-33.

Schelling G, Briegel J, Roozendaal B, Stoll C, Rothenhäusler HB, Kapfhammer HP. The effect of stress doses of hydrocortisone during septic shock on posttraumatic stress disorder in survivors. Biol Psychiatry. 2001 Dec 15;50(12):978-85.

Responsible Party:	Douglas L. Delahanty, PhD, Kent State University
ClinicalTrials.gov Identifier:	NCT00597857 History of Changes
Other Study ID Numbers:	05-025, R34MH073014
Study First Received:	January 10, 2008
Last Updated:	January 27, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cortisol succinate

Hydrocortisone acetate
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012