Status:
WITHDRAWN
Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
Lead Sponsor:
University of California, San Diego
Conditions:
Post-traumatic Stress Disorder
Eligibility:
MALE
18-65 years
Phase:
PHASE4
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 usi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00706173
Start Date
August 1 2009
End Date
September 1 2011
Last Update
June 3 2015
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92037