Phase 4 N=12 Randomized Triple-blind Treatment

Short Course Glucocorticoid Treatment for PTSD

Post-traumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00204737 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Change in Clinician-Administered PTSD Scale (CAPS) — 96.0; 90.7; 66.3; 86.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: prednisone (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Clinician-Administered PTSD Scale (CAPS)	96.0; 90.7; 66.3; 86.2; 72.8; 81.5	—
PRIMARY Number of Participants Achieving CAPS Response	4; 0; 3; 0; 1; 0	0.06
SECONDARY Change in Hamilton Depression Rating Scale (HAM-D)	19.2; 16.8; 13.2; 14.8; 11.7; 14.5	—
SECONDARY Change in PCL-PTSD Score	68.7; 64.2; 58.8; 59.8; 56.0; 60.3	—
SECONDARY Change in Clinical Global Impression Severity (CGI-S) Score	5.5; 5.5; 4.7; 5.5; 4.8; 5.2	—
SECONDARY Change in Dehydroepiandrosterone Sulfate (DHEA-S)	123.8; 201.2; 87.7; 148.7; 123.5; 156.8	—
SECONDARY Change in Salivary Cortisol (First 6 Participants)	0.13; 0.08; 0.10; 0.09; 0.10; 0.07	—
SECONDARY Change in Salivary Cortisol (Last 6 Participants)	0.1; 0.138; 0.103; 0.157; 0.112; 0.183	—
SECONDARY Change in Serum Glucose	—	—
SECONDARY Number of Other Adverse Events	2; 1; 3; 0; 2; 0	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00204737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.