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Short Course Glucocorticoid Treatment for PTSD

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.
 
ClinicalTrials.gov Identifier: NCT00204737
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Drug: prednisone Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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)
Study Start Date : December 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Active Comparator: Prednisone
Prednisone 20mg daily x 2 weeks
Drug: prednisone
20mg x 2 weeks

Placebo Comparator: placebo
placebo
Drug: placebo
placebo




Primary Outcome Measures :
  1. Change in Clinician-Administered PTSD Scale (CAPS) [ Time Frame: baseline, 2 weeks, 6 weeks, 12 weeks ]
    This measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms.

  2. Number of Participants Achieving CAPS Response [ Time Frame: baseline, 2 weeks, 6 weeks, 12 weeks ]
    CAPS response defined as a 30% reduction in CAPS score from baseline.


Secondary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale (HAM-D) [ Time Frame: baseline, 2 weeks, 6 weeks, 12 weeks ]
    HAM-D is a 21-item survey where scoring is based on the first 17-items. It has a total possible range of scores 0-50 where higher scores indicate more severe depression.

  2. Change in PCL-PTSD Score [ Time Frame: baseline, 2 weeks, 6 weeks, 12 weeks ]
    PCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms.

  3. Change in Clinical Global Impression Severity (CGI-S) Score [ Time Frame: baseline, 2 weeks, 6 weeks, 12 weeks ]
    CGI-S is scored by a clinician. It is a 7 point scale where 1 = normal, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill.

  4. Change in Dehydroepiandrosterone Sulfate (DHEA-S) [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks ]
    DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks

  5. Change in Salivary Cortisol (First 6 Participants) [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks ]
  6. Change in Salivary Cortisol (Last 6 Participants) [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks ]
    Participants provided saliva samples at 16:00, 24:00, and 08:00. After these samples are collected, participants take 0.5mg dexamethasone orally at 23:00, and a fourth sample is collected at 08:00 post dexamethasone. Post-dexamethasone data is reported here.

  7. Change in Serum Glucose [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks ]
  8. Number of Other Adverse Events [ Time Frame: up to 3 weeks ]
    The Systematic Assessment for Treatment Emergent Events-General Inquiry (SAFTEE-GI) was used to collect and analyze data about potential medication related side effects. Each of 12 subjects was queried using the SAFTEE-GI at 3 time points (1, 2 and 3 weeks) for a possible of 36 adverse event reports.



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

Inclusion Criteria:

  • Must meet Diagnostic and Statistical Manual of Mental Disorders (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
  • Chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes, rheumatologic diseases

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
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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
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Principal Investigator: Catherine D. Johnson, PharmD, MS, BCPP University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204737    
Other Study ID Numbers: H-2004-0039
First Posted: September 20, 2005    Key Record Dates
Results First Posted: May 6, 2020
Last Update Posted: May 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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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