Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
Developing novel and effective pharmacologic interventions for this post-traumatic stress disorder is important. The investigators propose to replicate findings of an earlier published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do so in a more meaningful way, the investigators will conduct a larger but similar randomized double-blind placebo-controlled, cross-over design treatment study examining the use of low dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.
The investigators hypothesize that, as described by Aerni et al. (2004), administration of daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for re-experiencing types (e.g., flashbacks, nightmares)of symptoms. The investigators also hope to examine potential predictors and moderators of treatment response based on subjects' clinical characteristics, as well as serum cortisol and ACTH levels.
Post-traumatic Stress Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder|
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]
- Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]
- Sheehan Disability Inventory (SDI) [ Time Frame: Week 0,4,6,10 ] [ Designated as safety issue: No ]
- Brief Symptom Inventory - 18 item (BSI-18) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Hydrocortisone 10-20 mg PO daily for 4 weeks.
Other Name: cortisol
|Placebo Comparator: Placebo||
Placebo "10-20 mg" PO daily for 4 weeks.
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Murray B Stein, MD, MPH||University of California, San Diego|