Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)

Study Overview
=================
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.

Official Title
-----------------
A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder

Conditions
-----------------
Post-traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: Hydrocortisone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br> | Drug: Hydrocortisone<br>* Hydrocortisone 10-20 mg PO daily for 4 weeks.<br>* Other names: cortisol;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo 10-20 mg PO daily for 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-traumatic stress disorder, PTSD, Cortisol, hydrocortisone, pharmacological treatment