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Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
This study is currently recruiting participants.
Study NCT00706173   Information provided by University of California, San Diego
First Received: June 25, 2008   Last Updated: August 19, 2009   History of Changes

June 25, 2008
August 19, 2009
August 2009
September 2011   (final data collection date for primary outcome measure)
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00706173 on ClinicalTrials.gov Archive Site
  • Sheehan Disability Inventory (SDI) [ Time Frame: Week 0,4,6,10 ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory - 18 item (BSI-18) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]
Same as current
 
Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder

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.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Post-Traumatic Stress Disorder
  • Drug: Hydrocortisone
  • Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
September 2011
September 2011   (final data collection date for primary outcome measure)

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)
Male
18 Years to 65 Years
No
Contact: Holly Ramsawh, PhD 858-534-6445 hramsawh@ucsd.edu
Contact: Murray B Stein, MD, MPH 858-534-6400 mstein@ucsd.edu
United States
 
NCT00706173
Murray B. Stein, University of California, San Diego
071982
University of California, San Diego
 
Principal Investigator: Murray B Stein, MD, MPH University of California, San Diego
University of California, San Diego
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP