MedPath

Short Course Glucocorticoid Treatment for PTSD

Phase 4
Completed
Conditions
Post-traumatic Stress Disorder
Interventions
Drug: placebo
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PrednisoneprednisonePrednisone 20mg daily x 2 weeks
placeboplaceboplacebo
Primary Outcome Measures
NameTimeMethod
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 Responsebaseline, 2 weeks, 6 weeks, 12 weeks

CAPS response defined as a 30% reduction in CAPS score from baseline.

Secondary Outcome Measures
NameTimeMethod
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 GlucoseBaseline, 2 weeks, 6 weeks, and 12 weeks
Number of Other Adverse Eventsup 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) Scorebaseline, 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 Scorebaseline, 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

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