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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Change from baseline to completion of therapy in HAM-D, PCL-PTSD, and CGI-S scores [ Time Frame: 3 years ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on September 21, 2017