Status:
UNKNOWN
A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
Lead Sponsor:
Bronx VA Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be...
Eligibility Criteria
Inclusion
- Age 18 to 89
- Capable of understanding, reading, and writing in English
- OIF/OEF veteran with criterion-A trauma while deployed
- Minimum PTSD severity of 60 (CAPS)
- Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)
Exclusion
- Lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive disorder
- Moderate or severe traumatic brain injury (TBI)
- A medical or mental health problem other than PTSD that requires immediate clinical attention
- Substance abuse or dependence within the last 3 months
- Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery-Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment
- Persons on a psychotropic medication regimen that has not been consistent for one month
- Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance)
- Unwillingness to discontinue other specialized psychotherapy for PTSD during the 11 weeks of study treatment and the 3 month follow-up (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated)
- Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01525680
Start Date
April 1 2011
Last Update
November 28 2013
Active Locations (1)
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1
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States, 10468