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

This study has been withdrawn prior to enrollment.
(Unable to recruit eligible subjects for the trial.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00706173
First Posted: June 27, 2008
Last Update Posted: June 3, 2015
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.
Information provided by:
University of California, San Diego
  Purpose

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 Intervention Phase
Post-traumatic Stress Disorder Drug: Hydrocortisone Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

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

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

Enrollment: 0
Study Start Date: August 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00706173


Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Murray B Stein, MD, MPH University of California, San Diego
  More Information

Additional Information:
Publications:
Responsible Party: Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00706173     History of Changes
Other Study ID Numbers: 071982
First Submitted: June 25, 2008
First Posted: June 27, 2008
Last Update Posted: June 3, 2015
Last Verified: August 2011

Keywords provided by University of California, San Diego:
Post-traumatic stress disorder
PTSD
Cortisol
hydrocortisone
pharmacological treatment

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents