Short Course Glucocorticoid Treatment for PTSD

A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204737

Enrollment

Registered

2005-09-20

Start date

2004-12-31

Completion date

2009-01-31

Last updated

2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Disorder

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

Interventions

DRUGprednisone

20mg x 2 weeks

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.
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
Change in Salivary Cortisol (First 6 Participants)	Baseline, 2 weeks, 6 weeks, and 12 weeks	—
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.
Change in Serum Glucose	Baseline, 2 weeks, 6 weeks, and 12 weeks	—
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Prednisone Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks	6
Placebo placebo placebo: placebo	6
Total	12

Baseline characteristics

Characteristic	Placebo	Total	Prednisone
Age, Continuous	56.0 years STANDARD_DEVIATION 4.9	54 years STANDARD_DEVIATION 7.8	53.5 years STANDARD_DEVIATION 10.3
Education Level Bachelor's or Technical School	1 Participants	3 Participants	2 Participants
Education Level High School / GED	4 Participants	7 Participants	3 Participants
Education Level Some College	1 Participants	2 Participants	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants	11 Participants	6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Marital Status Divorced	4 Participants	7 Participants	3 Participants
Marital Status Married	2 Participants	4 Participants	2 Participants
Marital Status Widowed	0 Participants	1 Participants	1 Participants
Percent Service Connection 0 percent	1 Participants	2 Participants	1 Participants
Percent Service Connection 100 percent	0 Participants	2 Participants	2 Participants
Percent Service Connection 1-30 percent	2 Participants	2 Participants	0 Participants
Percent Service Connection 31-60 percent	0 Participants	0 Participants	0 Participants
Percent Service Connection 61-99 percent	3 Participants	6 Participants	3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	5 Participants	11 Participants	6 Participants
Region of Enrollment United States	6 participants	12 participants	6 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	6 Participants	12 Participants	6 Participants
Trauma Type Childhood Abuse	1 Participants	2 Participants	1 Participants
Trauma Type Combat	4 Participants	9 Participants	5 Participants
Trauma Type Employment	1 Participants	1 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 6	0 / 6
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 6	0 / 6

Outcome results

Primary

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.

Time frame: baseline, 2 weeks, 6 weeks, 12 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Prednisone	Change in Clinician-Administered PTSD Scale (CAPS)	Baseline	96.0 score on a scale	Standard Deviation 17.1
Prednisone	Change in Clinician-Administered PTSD Scale (CAPS)	2 Weeks	66.3 score on a scale	Standard Deviation 18.6
Prednisone	Change in Clinician-Administered PTSD Scale (CAPS)	6 Weeks	72.8 score on a scale	Standard Deviation 18.2
Prednisone	Change in Clinician-Administered PTSD Scale (CAPS)	12 Weeks	75.2 score on a scale	Standard Deviation 27
Placebo	Change in Clinician-Administered PTSD Scale (CAPS)	12 Weeks	82.5 score on a scale	Standard Deviation 18.7
Placebo	Change in Clinician-Administered PTSD Scale (CAPS)	Baseline	90.7 score on a scale	Standard Deviation 13.3
Placebo	Change in Clinician-Administered PTSD Scale (CAPS)	6 Weeks	81.5 score on a scale	Standard Deviation 11.6
Placebo	Change in Clinician-Administered PTSD Scale (CAPS)	2 Weeks	86.2 score on a scale	Standard Deviation 21

Primary

Number of Participants Achieving CAPS Response

CAPS response defined as a 30% reduction in CAPS score from baseline.

Time frame: baseline, 2 weeks, 6 weeks, 12 weeks

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Prednisone	Number of Participants Achieving CAPS Response	baseline to 2 weeks	4 Participants
Prednisone	Number of Participants Achieving CAPS Response	baseline to 6 weeks	3 Participants
Prednisone	Number of Participants Achieving CAPS Response	baseline to 12 weeks	1 Participants
Placebo	Number of Participants Achieving CAPS Response	baseline to 2 weeks	0 Participants
Placebo	Number of Participants Achieving CAPS Response	baseline to 6 weeks	0 Participants
Placebo	Number of Participants Achieving CAPS Response	baseline to 12 weeks	0 Participants

Comparison: comparison at 2 Weeksp-value: 0.06Fisher Exact

Comparison: Comparison at 6 Weeksp-value: 0.18Fisher Exact

Comparison: Comparison at 12 weeksp-value: 0.5Fisher Exact

Secondary

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.

Time frame: baseline, 2 weeks, 6 weeks, 12 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Prednisone	Change in Clinical Global Impression Severity (CGI-S) Score	Baseline	5.5 score on a scale	Standard Deviation 1
Prednisone	Change in Clinical Global Impression Severity (CGI-S) Score	2 Weeks	4.7 score on a scale	Standard Deviation 0.8
Prednisone	Change in Clinical Global Impression Severity (CGI-S) Score	6 Weeks	4.8 score on a scale	Standard Deviation 0.8
Prednisone	Change in Clinical Global Impression Severity (CGI-S) Score	12 Weeks	4.5 score on a scale	Standard Deviation 1
Placebo	Change in Clinical Global Impression Severity (CGI-S) Score	12 Weeks	5.5 score on a scale	Standard Deviation 1
Placebo	Change in Clinical Global Impression Severity (CGI-S) Score	Baseline	5.5 score on a scale	Standard Deviation 0.8
Placebo	Change in Clinical Global Impression Severity (CGI-S) Score	6 Weeks	5.2 score on a scale	Standard Deviation 0.8
Placebo	Change in Clinical Global Impression Severity (CGI-S) Score	2 Weeks	5.5 score on a scale	Standard Deviation 0.8

Secondary

Change in Dehydroepiandrosterone Sulfate (DHEA-S)

DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks

Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Prednisone	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	Baseline	123.8 mcg/dl	Standard Deviation 115
Prednisone	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	6 Weeks	123.5 mcg/dl	Standard Deviation 116.2
Prednisone	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	2 Weeks	87.7 mcg/dl	Standard Deviation 105.6
Prednisone	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	12 Weeks	112.3 mcg/dl	Standard Deviation 117.4
Placebo	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	12 Weeks	157.8 mcg/dl	Standard Deviation 211.8
Placebo	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	Baseline	201.2 mcg/dl	Standard Deviation 280.2
Placebo	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	2 Weeks	148.7 mcg/dl	Standard Deviation 170.8
Placebo	Change in Dehydroepiandrosterone Sulfate (DHEA-S)	6 Weeks	156.8 mcg/dl	Standard Deviation 188.3

Secondary

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.

Time frame: baseline, 2 weeks, 6 weeks, 12 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Prednisone	Change in Hamilton Depression Rating Scale (HAM-D)	Baseline	19.2 score on a scale	Standard Deviation 7.2
Prednisone	Change in Hamilton Depression Rating Scale (HAM-D)	2 Weeks	13.2 score on a scale	Standard Deviation 6.1
Prednisone	Change in Hamilton Depression Rating Scale (HAM-D)	6 Weeks	11.7 score on a scale	Standard Deviation 5.9
Prednisone	Change in Hamilton Depression Rating Scale (HAM-D)	12 Weeks	12.3 score on a scale	Standard Deviation 5.7
Placebo	Change in Hamilton Depression Rating Scale (HAM-D)	12 Weeks	15.7 score on a scale	Standard Deviation 5.9
Placebo	Change in Hamilton Depression Rating Scale (HAM-D)	Baseline	16.8 score on a scale	Standard Deviation 5.8
Placebo	Change in Hamilton Depression Rating Scale (HAM-D)	6 Weeks	14.5 score on a scale	Standard Deviation 6.2
Placebo	Change in Hamilton Depression Rating Scale (HAM-D)	2 Weeks	14.8 score on a scale	Standard Deviation 6.7

Secondary

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.

Time frame: baseline, 2 weeks, 6 weeks, 12 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Prednisone	Change in PCL-PTSD Score	Baseline	68.7 score on a scale	Standard Deviation 10.6
Prednisone	Change in PCL-PTSD Score	6 Weeks	56.0 score on a scale	Standard Deviation 13.3
Prednisone	Change in PCL-PTSD Score	2 Weeks	58.8 score on a scale	Standard Deviation 7.5
Prednisone	Change in PCL-PTSD Score	12 Weeks	58.2 score on a scale	Standard Deviation 15.6
Placebo	Change in PCL-PTSD Score	2 Weeks	59.8 score on a scale	Standard Deviation 8
Placebo	Change in PCL-PTSD Score	Baseline	64.2 score on a scale	Standard Deviation 9.5
Placebo	Change in PCL-PTSD Score	12 Weeks	64.2 score on a scale	Standard Deviation 8.4
Placebo	Change in PCL-PTSD Score	6 Weeks	60.3 score on a scale	Standard Deviation 6

Secondary

Change in Salivary Cortisol (First 6 Participants)

Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Prednisone	Change in Salivary Cortisol (First 6 Participants)	Baseline	0.13 ug/dl	Standard Deviation 0.05
Prednisone	Change in Salivary Cortisol (First 6 Participants)	6 Weeks	0.10 ug/dl	Standard Deviation 0.02
Prednisone	Change in Salivary Cortisol (First 6 Participants)	12 Weeks	0.10 ug/dl	Standard Deviation 0.01
Placebo	Change in Salivary Cortisol (First 6 Participants)	Baseline	0.08 ug/dl	Standard Deviation 0.03
Placebo	Change in Salivary Cortisol (First 6 Participants)	6 Weeks	0.09 ug/dl	Standard Deviation 0.03
Placebo	Change in Salivary Cortisol (First 6 Participants)	12 Weeks	0.07 ug/dl	Standard Deviation 0.03

Secondary

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.

Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Prednisone	Change in Salivary Cortisol (Last 6 Participants)	Baseline	0.1 ug/dl	Standard Deviation 0.1
Prednisone	Change in Salivary Cortisol (Last 6 Participants)	6 Weeks	0.103 ug/dl	—
Prednisone	Change in Salivary Cortisol (Last 6 Participants)	12 Weeks	0.112 ug/dl	Standard Deviation 0.122
Placebo	Change in Salivary Cortisol (Last 6 Participants)	Baseline	0.138 ug/dl	Standard Deviation 0.067
Placebo	Change in Salivary Cortisol (Last 6 Participants)	6 Weeks	0.157 ug/dl	Standard Deviation 0.021
Placebo	Change in Salivary Cortisol (Last 6 Participants)	12 Weeks	0.183 ug/dl	Standard Deviation 0.067

Secondary

Change in Serum Glucose

Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks

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

Secondary

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.

Time frame: up to 3 weeks

Arm	Measure	Group	Value (NUMBER)
Prednisone	Number of Other Adverse Events	Reduced Blood Sugar	2 incidence of adverse events
Prednisone	Number of Other Adverse Events	Upper Respiratory Infection	1 incidence of adverse events
Prednisone	Number of Other Adverse Events	Sleeplessness	3 incidence of adverse events
Prednisone	Number of Other Adverse Events	Increased Mood	1 incidence of adverse events
Prednisone	Number of Other Adverse Events	Decreased Energy	0 incidence of adverse events
Prednisone	Number of Other Adverse Events	Mild Urinary Hesitancy	0 incidence of adverse events
Prednisone	Number of Other Adverse Events	Musculoskeletal	2 incidence of adverse events
Placebo	Number of Other Adverse Events	Mild Urinary Hesitancy	1 incidence of adverse events
Placebo	Number of Other Adverse Events	Musculoskeletal	1 incidence of adverse events
Placebo	Number of Other Adverse Events	Sleeplessness	0 incidence of adverse events
Placebo	Number of Other Adverse Events	Reduced Blood Sugar	0 incidence of adverse events
Placebo	Number of Other Adverse Events	Decreased Energy	1 incidence of adverse events
Placebo	Number of Other Adverse Events	Upper Respiratory Infection	1 incidence of adverse events
Placebo	Number of Other Adverse Events	Increased Mood	0 incidence of adverse events

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Short Course Glucocorticoid Treatment for PTSD

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Change in Clinician-Administered PTSD Scale (CAPS)

Number of Participants Achieving CAPS Response

Change in Clinical Global Impression Severity (CGI-S) Score

Change in Dehydroepiandrosterone Sulfate (DHEA-S)

Change in Hamilton Depression Rating Scale (HAM-D)

Change in PCL-PTSD Score

Change in Salivary Cortisol (First 6 Participants)

Change in Salivary Cortisol (Last 6 Participants)

Change in Serum Glucose

Number of Other Adverse Events