Short Course Glucocorticoid Treatment for PTSD

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 12, 2005
Last updated: September 29, 2015
Last verified: September 2015
The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone in addition to standard care will result in reduced PTSD symptoms or symptom severity compared to placebo

Condition Intervention
Post-traumatic Stress Disorder
Drug: prednisone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 30% or greater improvement in the Clinician-Administered PTSD Scale [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to completion of therapy in HAM-D, PCL-PTSD, and CGI-S scores [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    see above

Enrollment: 12
Study Start Date: December 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prednisone
Prednisone 20mg daily x 2 weeks
Drug: prednisone
20mg x 2 weeks
Placebo Comparator: placebo
Drug: placebo

Detailed Description:
See attached document

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must meet DSM-IV criteria for PTSD w/ symptom exacerbation (CAPS score ≥ 50)
  • Stable on other psychotropic meds x1 month

Exclusion Criteria:

  • Current or past history of bipolar, schizophrenic, or other psychotic disorder
  • Organic mental disorder
  • Alcohol or substance abuse in last 3 months
  • Clinically significant hepatic or renal disease or other acute or unstable medical condition
  • COPD, asthma, uncontrolled diabetes, rheumatologic diseases
  Contacts and Locations
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Please refer to this study by its identifier: NCT00204737

United States, Wisconsin
Catherine Johnson
Madison, Wisconsin, United States, 53711
Wm. S. Middleton VA Hospital
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Catherine D. Johnson, PharmD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00204737     History of Changes
Other Study ID Numbers: H2004-0039 
Study First Received: September 12, 2005
Last Updated: September 29, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 10, 2016