Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Short Course Glucocorticoid Treatment for PTSD

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204737
First received: September 12, 2005
Last updated: July 9, 2010
Last verified: July 2010
  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
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
placebo
Drug: placebo
placebo

Detailed Description:

See attached document

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Catherine Johnson, Madison VA Hospital
ClinicalTrials.gov Identifier: NCT00204737     History of Changes
Other Study ID Numbers: H2004-0039
Study First Received: September 12, 2005
Last Updated: July 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014