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

NCT00597857 | Unknown DMC

• 2 other identifiers: 05-025R34MH073014
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale (CAPS)

  one- and three-months post-trauma

Study Arms (2)

1

PLACEBO COMPARATOR

receipt of a placebo pill for 16 days

Drug: placebo

2

ACTIVE COMPARATOR

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

Interventions

Hydrocortisone DRUG

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

Also known as: Cortisol, Cortef, Hydrocortone

2

placebo DRUG

receipt of a placebo pill for 16 days

1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kent State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Akron City Hospital

Akron, Ohio, 44309, United States

RECRUITING

Related Publications (8)

• 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. doi: 10.1016/s0006-3223(00)00896-9.

  PMID: 11074232 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1080/02699050110065682.

  PMID: 11595084 BACKGROUND

• 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. doi: 10.1016/s0887-6185(02)00185-8.

  PMID: 12614659 BACKGROUND

• 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. doi: 10.1080/09540120410001641084.

  PMID: 14676029 BACKGROUND

• 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. doi: 10.1016/s0006-3223(01)01279-3.

  PMID: 11822998 BACKGROUND

• Schelling G, Kilger E, Roozendaal B, de Quervain DJ, Briegel J, Dagge A, Rothenhausler 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. doi: 10.1016/j.biopsych.2003.09.014.

  PMID: 15013832 BACKGROUND

• Schelling G, Briegel J, Roozendaal B, Stoll C, Rothenhausler 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. doi: 10.1016/s0006-3223(01)01270-7.

  PMID: 11750894 BACKGROUND

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

• Doulas L Delahanty, PhD

  Kent State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas L Delahanty, PhD

CONTACT

(330) 672-2395; ddelahan@kent.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 18, 2008
• Study Start: June 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

US (1)