Post-traumatic Stress Disorder
Conditions
Keywords
Post-traumatic stress disorder, PTSD, Cortisol, hydrocortisone, pharmacological treatment
Brief summary
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.
Interventions
DRUGHydrocortisone
Hydrocortisone 10-20 mg PO daily for 4 weeks.
DRUGPlacebo
Placebo 10-20 mg PO daily for 4 weeks.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male military veterans * Between the ages of 18-65 years old * Generally good medical health with no clinically significant abnormalities on physical examination, electrocardiogram, or laboratory findings * Ability to provide informed consent and comply with requirements of study protocol * No specific contraindications to hydrocortisone * Clinically predominant DSM-IV diagnosis of PTSD * Score of ≥ 40 on Clinician Administered PTSD Scale \[CAPS\]
Exclusion criteria
* History of moderate to severe traumatic brain injury, seizure or organic mental illness * Lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or depression with a score of ≥ 16 on the 17-item Hamilton Depression Rating Scale (Hamilton, 1960), active suicidal ideation * Unstable medical illness * Subjects undergoing any formal psychotherapy within 3 months of enrollment * Subjects that meet criteria for substance dependence during the last 6 months * History of adverse reaction to corticosteroids. * Concurrent use of other psychotropic medication (e.g. benzodiazepines, antipsychotics)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinician Administered PTSD Scale (CAPS) | Week 0,2,4,6,8,10 |
| Clinical Global Impressions - Improvement (CGI-I) | Week 0,2,4,6,8,10 |
Secondary
| Measure | Time frame |
|---|---|
| Sheehan Disability Inventory (SDI) | Week 0,4,6,10 |
| Brief Symptom Inventory - 18 item (BSI-18) | Week 0,2,4,6,8,10 |
Countries
United States
Outcome results
None listed