Short Course Glucocorticoid Treatment for PTSD

Study Overview
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Brief Summary
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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

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

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Drug: prednisone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisone<br>Prednisone 20mg daily x 2 weeks | Drug: prednisone<br>* 20mg x 2 weeks<br>|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline, 2 weeks, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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 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. | 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 | 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. | up to 3 weeks |