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Sponsors and Collaborators: |
Kent State University National Institute of Mental Health (NIMH) |
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Information provided by: | Kent State University |
ClinicalTrials.gov Identifier: | NCT00597857 |
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 (as in the toss of a coin) to one of two treatment groups. You 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 you nor the experimenters will know which treatment you received (except in case of an emergency).
Condition | Intervention |
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Posttraumatic Stress Disorder |
Drug: Hydrocortisone |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of PTSD With Early Hydrocortisone Treatment: Pilot |
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 |
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1: Placebo Comparator
receipt of a placebo pill for 10 days
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Drug: Hydrocortisone
Participants will receive a tapering low-dose of hydrocortisone in pill form for 16 days, twice a day, after the trauma.
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2: Active Comparator
oral pill of hydrocortisone (propranolol HCL 20 mg twice daily for 16 days (and taper for 5 days; based on Pitman et al, 2002).
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Drug: Hydrocortisone
Participants will receive a tapering low-dose of hydrocortisone in pill form for 16 days, twice a day, after the trauma.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Douglas L Delahanty, PhD | (330) 672-2395 | ddelahan@kent.edu |
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 |
Principal Investigator: | Doulas L Delahanty, PhD | Kent State University |
Responsible Party: | Kent State University ( Douglas L. Delahanty, PhD ) |
Study ID Numbers: | 05-025, R34MH073014 |
Study First Received: | January 10, 2008 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00597857 |
Health Authority: | United States: Institutional Review Board |
Hydrocortisone Cortisol succinate Anxiety Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Hydrocortisone acetate Stress Disorders, Traumatic |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |