search
Back to results

Short Course Glucocorticoid Treatment for PTSD

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
prednisone
placebo
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catherine Johnson
  • Wm. S. Middleton VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prednisone

placebo

Arm Description

Prednisone 20mg daily x 2 weeks

placebo

Outcomes

Primary Outcome Measures

Change in Clinician-Administered PTSD Scale (CAPS)
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.
Number of Participants Achieving CAPS Response
CAPS response defined as a 30% reduction in CAPS score from baseline.

Secondary Outcome Measures

Change in Hamilton Depression Rating Scale (HAM-D)
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.
Change in PCL-PTSD Score
PCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms.
Change in Clinical Global Impression Severity (CGI-S) Score
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.
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks
Change in Salivary Cortisol (First 6 Participants)
Change in Salivary Cortisol (Last 6 Participants)
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.
Change in Serum Glucose
Number of Other Adverse Events
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.

Full Information

First Posted
September 12, 2005
Last Updated
April 27, 2020
Sponsor
University of Wisconsin, Madison
search

1. Study Identification

Unique Protocol Identification Number
NCT00204737
Brief Title
Short Course Glucocorticoid Treatment for PTSD
Official Title
A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Prednisone 20mg daily x 2 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
20mg x 2 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change in Clinician-Administered PTSD Scale (CAPS)
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Number of Participants Achieving CAPS Response
Description
CAPS response defined as a 30% reduction in CAPS score from baseline.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale (HAM-D)
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Change in PCL-PTSD Score
Description
PCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Change in Clinical Global Impression Severity (CGI-S) Score
Description
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.
Time Frame
baseline, 2 weeks, 6 weeks, 12 weeks
Title
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
Description
DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks
Time Frame
Baseline, 2 weeks, 6 weeks, and 12 weeks
Title
Change in Salivary Cortisol (First 6 Participants)
Time Frame
Baseline, 2 weeks, 6 weeks, and 12 weeks
Title
Change in Salivary Cortisol (Last 6 Participants)
Description
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.
Time Frame
Baseline, 2 weeks, 6 weeks, and 12 weeks
Title
Change in Serum Glucose
Time Frame
Baseline, 2 weeks, 6 weeks, and 12 weeks
Title
Number of Other Adverse Events
Description
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.
Time Frame
up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine D. Johnson, PharmD, MS, BCPP
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catherine Johnson
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States
Facility Name
Wm. S. Middleton VA Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Short Course Glucocorticoid Treatment for PTSD

We'll reach out to this number within 24 hrs