COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00706173
Recruitment Status : Withdrawn (Unable to recruit eligible subjects for the trial.)
First Posted : June 27, 2008
Last Update Posted : June 3, 2015
Information provided by:
University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Drug: Hydrocortisone Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder
Study Start Date : August 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Hydrocortisone Drug: Hydrocortisone
Hydrocortisone 10-20 mg PO daily for 4 weeks.
Other Name: cortisol

Placebo Comparator: Placebo Drug: Placebo
Placebo "10-20 mg" PO daily for 4 weeks.

Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 0,2,4,6,8,10 ]
  2. Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: Week 0,2,4,6,8,10 ]

Secondary Outcome Measures :
  1. Sheehan Disability Inventory (SDI) [ Time Frame: Week 0,4,6,10 ]
  2. Brief Symptom Inventory - 18 item (BSI-18) [ Time Frame: Week 0,2,4,6,8,10 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00706173

Layout table for location information
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Layout table for investigator information
Principal Investigator: Murray B Stein, MD, MPH University of California, San Diego
Additional Information:
Layout table for additonal information
Responsible Party: Murray B. Stein, University of California, San Diego Identifier: NCT00706173    
Other Study ID Numbers: 071982
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: August 2011
Keywords provided by University of California, San Diego:
Post-traumatic stress disorder
pharmacological treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Anti-Inflammatory Agents