Status:
COMPLETED
Cortisol Augmentation of Prolonged Exposure Therapy
Lead Sponsor:
VISN 3 Mental Illness Research, Education and Clinical Center
Conditions:
PTSD
Eligibility:
All Genders
18+ 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
- Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months
- Capable of understanding, reading and writing English
Exclusion
- Incapable and/or unwilling to provide written informed consent prior to participation
- Unwilling and/or unable to discontinue current psychotherapy
- Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra)
- Regular use of oral or inhaled steroids
- Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.)
- The veteran, the veteran's physician, or the study physician think that the veteran's clinical state necessitates the prompt initiation of pharmacotherapy or other treatment that would preclude involvement in the study
- Morbid obesity (VMI \> 40)
- Clinically significant laboratory abnormalities as determine during medical clearance procedures
- For women, a positive pregnancy test
- Heavy smoking (more than 2 packs a day)
- Substance and/or alcohol abuse and/or dependence within the previous 6 months
- Response of 3 or 4 on the suicidality items of the HDRS or an assessed serious suicide risk
- Current psychosocial problems that might interfere with treatment compliance
- A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder or PTSD due to a trauma not sustained in the combat theater
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00751855
Start Date
July 1 2008
End Date
February 1 2011
Last Update
July 27 2012
Active Locations (1)
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1
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States, 10468