Short Course Glucocorticoid Treatment for PTSD

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00204737
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arms: 2
• Duration (Months): 49
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder	Drug: prednisone; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• 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: Dec 1, 2004
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Clinician-Administered PTSD Scale (CAPS) [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 [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) [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 [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 [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) [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) [Baseline, 2 weeks, 6 weeks, and 12 weeks]

6. Change in Salivary Cortisol (Last 6 Participants) [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 [Baseline, 2 weeks, 6 weeks, and 12 weeks]

8. Number of Other Adverse Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catherine Johnson	Madison	Wisconsin	United States	53711
2	Wm. S. Middleton VA Hospital	Madison	Wisconsin	United States	53711

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Catherine D. Johnson, PharmD, MS, BCPP, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00204737
• Other Study ID Numbers: H-2004-0039
• First Posted: Sep 20, 2005
• Last Update Posted: May 6, 2020
• Last Verified: Apr 1, 2020

• 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: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Prednisone

Study Results

Participant Flow

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Period Title: Overall Study
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Prednisone	Placebo	Total
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo	Total of all reporting groups
Overall Participants	6	6	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.5 (10.3)	56.0 (4.9)	54 (7.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	6 100%	6 100%	12 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 16.7%	1 8.3%
Not Hispanic or Latino	6 100%	5 83.3%	11 91.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	6 100%	5 83.3%	11 91.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 16.7%	1 8.3%
Region of Enrollment (participants) [Number]
United States	6 100%	6 100%	12 100%
Marital Status (Count of Participants)
Married	2 33.3%	2 33.3%	4 33.3%
Divorced	3 50%	4 66.7%	7 58.3%
Widowed	1 16.7%	0 0%	1 8.3%
Trauma Type (Count of Participants)
Combat	5 83.3%	4 66.7%	9 75%
Childhood Abuse	1 16.7%	1 16.7%	2 16.7%
Employment	0 0%	1 16.7%	1 8.3%
Education Level (Count of Participants)
High School / GED	3 50%	4 66.7%	7 58.3%
Some College	1 16.7%	1 16.7%	2 16.7%
Bachelor's or Technical School	2 33.3%	1 16.7%	3 25%
Percent Service Connection (Count of Participants)
0 percent	1 16.7%	1 16.7%	2 16.7%
1-30 percent	0 0%	2 33.3%	2 16.7%
31-60 percent	0 0%	0 0%	0 0%
61-99 percent	3 50%	3 50%	6 50%
100 percent	2 33.3%	0 0%	2 16.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	6	6
Baseline	96.0 (17.1)	90.7 (13.3)
2 Weeks	66.3 (18.6)	86.2 (21.0)
6 Weeks	72.8 (18.2)	81.5 (11.6)
12 Weeks	75.2 (27.0)	82.5 (18.7)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	6	6
baseline to 2 weeks	4 66.7%	0 0%
baseline to 6 weeks	3 50%	0 0%
baseline to 12 weeks	1 16.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prednisone, Placebo
	Comments	comparison at 2 Weeks
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prednisone, Placebo
	Comments	Comparison at 6 Weeks
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prednisone, Placebo
	Comments	Comparison at 12 weeks
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	6	6
Baseline	19.2 (7.2)	16.8 (5.8)
2 Weeks	13.2 (6.1)	14.8 (6.7)
6 Weeks	11.7 (5.9)	14.5 (6.2)
12 Weeks	12.3 (5.7)	15.7 (5.9)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	6	6
Baseline	68.7 (10.6)	64.2 (9.5)
2 Weeks	58.8 (7.5)	59.8 (8.0)
6 Weeks	56.0 (13.3)	60.3 (6.0)
12 Weeks	58.2 (15.6)	64.2 (8.4)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	6	6
Baseline	5.5 (1.0)	5.5 (0.8)
2 Weeks	4.7 (0.8)	5.5 (0.8)
6 Weeks	4.8 (0.8)	5.2 (0.8)
12 Weeks	4.5 (1.0)	5.5 (1.0)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	6	6
Baseline	123.8 (115.0)	201.2 (280.2)
2 Weeks	87.7 (105.6)	148.7 (170.8)
6 Weeks	123.5 (116.2)	156.8 (188.3)
12 Weeks	112.3 (117.4)	157.8 (211.8)

7. Secondary Outcome

Title	Change in Salivary Cortisol (First 6 Participants)
Time Frame	Baseline, 2 weeks, 6 weeks, and 12 weeks

Outcome Measure Data

Analysis Population Description

Midway through the study, the protocol related to salivary cortisol was modified to add the dexamethasone suppression test to better understand response of the hypothalamic pituitary adrenal (HPA) axis to a steroid challenge. This is why no participants were analyzed during week 2.

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	3	3
Baseline	0.13 (0.05)	0.08 (0.03)
6 Weeks	0.10 (0.02)	0.09 (0.03)
12 Weeks	0.10 (0.01)	0.07 (0.03)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant in the Prednisone arm did not provide enough sample for analysis and one additional participant in the Prednisone arm did not provide enough sample for analysis at week 6. Data was not collected for week 2 due to protocol amendment to change cortisol testing.

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	2	3
Baseline	0.1 (0.1)	0.138 (0.067)
6 Weeks	0.103 (NA)	0.157 (0.021)
12 Weeks	0.112 (0.122)	0.183 (0.067)

9. Secondary Outcome

Title	Change in Serum Glucose
Time Frame	Baseline, 2 weeks, 6 weeks, and 12 weeks

Outcome Measure Data

Analysis Population Description

Data no longer exists in the research file depository due it its vintage. Unable to report this measure.

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	0	0

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisone	Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	placebo placebo: placebo
Measure Participants	6	6
Musculoskeletal	2	1
Sleeplessness	3	0
Reduced Blood Sugar	2	0
Decreased Energy	0	1
Upper Respiratory Infection	1	1
Increased Mood	1	0
Mild Urinary Hesitancy	0	1

Adverse Events

Time Frame	up to 3 weeks
Adverse Event Reporting Description	There is no longer access to total participants affected by Other Adverse Events, therefore we report 0 participants affected and at risk in this table. Please refer to Outcome Measure 10 where the available Other Adverse Event information for this study is reported.
Arm/Group Title	Prednisone		Placebo
Arm/Group Description	Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks		placebo placebo: placebo
All Cause Mortality
	Prednisone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Prednisone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Prednisone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.