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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
20mg x 2 weeks
placebo
Catherine Johnson
Madison, Wisconsin, United States
Wm. S. Middleton VA Hospital
Madison, Wisconsin, United States
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
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
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
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
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
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
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Change in Salivary Cortisol (First 6 Participants)
Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks
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
Change in Serum Glucose
Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks
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