A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)
Overview
- Phase
- Phase 4
- Intervention
- prednisone
- Conditions
- Post-traumatic Stress Disorder
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Change in Clinician-Administered PTSD Scale (CAPS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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
Investigators
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
Arms & Interventions
Prednisone
Prednisone 20mg daily x 2 weeks
Intervention: prednisone
placebo
placebo
Intervention: placebo
Outcomes
Primary Outcomes
Change in Clinician-Administered PTSD Scale (CAPS)
Time Frame: 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
Time Frame: baseline, 2 weeks, 6 weeks, 12 weeks
CAPS response defined as a 30% reduction in CAPS score from baseline.
Secondary Outcomes
- Change in Salivary Cortisol (First 6 Participants)(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Change in Salivary Cortisol (Last 6 Participants)(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Change in Serum Glucose(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Number of Other Adverse Events(up to 3 weeks)
- Change in Clinical Global Impression Severity (CGI-S) Score(baseline, 2 weeks, 6 weeks, 12 weeks)
- Change in Dehydroepiandrosterone Sulfate (DHEA-S)(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Change in Hamilton Depression Rating Scale (HAM-D)(baseline, 2 weeks, 6 weeks, 12 weeks)
- Change in PCL-PTSD Score(baseline, 2 weeks, 6 weeks, 12 weeks)