Short Course Glucocorticoid Treatment for PTSD

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204737
• Other study ID #: H-2004-0039
• Status: Completed
• Phase: Phase 4
• Start date: December 2004
• Est. completion date: January 2009

Study information

• Verified date: April 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• prednisone
20mg x 2 weeks
• placebo
placebo

Locations

Country	Name	City	State
United States	Catherine Johnson	Madison	Wisconsin
United States	Wm. S. Middleton VA Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Salivary Cortisol (First 6 Participants)		Baseline, 2 weeks, 6 weeks, and 12 weeks
Secondary	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
Secondary	Change in Serum Glucose		Baseline, 2 weeks, 6 weeks, and 12 weeks
Secondary	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