Short Course Glucocorticoid Treatment for PTSD

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

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 Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Drug: placebo; Drug: prednisone

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • Catherine Johnson
    • Madison, Wisconsin, United States, 53711
      • Wm. S. Middleton VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; placebo
Active Comparator: Prednisone; Prednisone 20mg daily x 2 weeks	Drug: prednisone; 20mg x 2 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Catherine D. Johnson, PharmD, MS, BCPP, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: H-2004-0039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No