Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
|ClinicalTrials.gov Identifier: NCT00706173|
Recruitment Status : Withdrawn (Unable to recruit eligible subjects for the trial.)
First Posted : June 27, 2008
Last Update Posted : June 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Stress Disorder||Drug: Hydrocortisone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
Hydrocortisone 10-20 mg PO daily for 4 weeks.
Other Name: cortisol
|Placebo Comparator: Placebo||
Placebo "10-20 mg" PO daily for 4 weeks.
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 0,2,4,6,8,10 ]
- Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: Week 0,2,4,6,8,10 ]
- Sheehan Disability Inventory (SDI) [ Time Frame: Week 0,4,6,10 ]
- Brief Symptom Inventory - 18 item (BSI-18) [ Time Frame: Week 0,2,4,6,8,10 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706173
|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|