Short Course Glucocorticoid Treatment for PTSD - Full Text View

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00204737

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:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Prednisone

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204737

Locations

United States, Wisconsin
Wm. S. Middleton VA Hospital
Madison, Wisconsin, United States, 53711
Catherine Johnson
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:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Glucocorticoids
Prednisone
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012