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

June 2, 2015 updated by: University of California, San Diego

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo "10-20 mg" PO daily for 4 weeks.
EXPERIMENTAL: Hydrocortisone
Drug: Hydrocortisone
Hydrocortisone 10-20 mg PO daily for 4 weeks.
Other Names:
  • cortisol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ANTICIPATED)

September 1, 2011

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (ESTIMATE)

June 27, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 071982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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