Short Course Glucocorticoid Treatment for PTSD
- Registration Number
- NCT00204737
- Lead Sponsor
- University of Wisconsin, Madison
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prednisone prednisone Prednisone 20mg daily x 2 weeks placebo placebo placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 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.
Trial Locations
- Locations (2)
Catherine Johnson
🇺🇸Madison, Wisconsin, United States
Wm. S. Middleton VA Hospital
🇺🇸Madison, Wisconsin, United States