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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This study has been withdrawn prior to enrollment.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:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00706173
First received: June 25, 2008
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
UCSD Anxiety Disorders Research Program  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00706173     History of Changes
Other Study ID Numbers: 071982
Study First Received: June 25, 2008
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
 Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013