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Short Course Glucocorticoid Treatment for PTSD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204737
First Posted: September 20, 2005
Last Update Posted: October 1, 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 (Responsible Party):
University of Wisconsin, Madison
  Purpose
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
placebo
Drug: placebo
placebo

Detailed Description:
See attached document
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00204737


Locations
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
Investigators
Principal Investigator: Catherine D. Johnson, PharmD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204737     History of Changes
Other Study ID Numbers: H2004-0039
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: October 1, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents