Short Course Glucocorticoid Treatment for PTSD

• ClinicalTrials.gov Identifier: NCT00204737
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Results First Posted: May 6, 2020
• Last Update Posted: May 6, 2020
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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

Condition or disease	Intervention/treatment	Phase
Post-traumatic Stress Disorder	Drug: prednisone; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)
• Study Start Date: December 2004
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 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.
2. Number of Participants Achieving CAPS Response [ Time Frame: baseline, 2 weeks, 6 weeks, 12 weeks ]
   CAPS response defined as a 30% reduction in CAPS score from baseline.

Secondary Outcome Measures :

1. Change in Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 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.
2. Change in PCL-PTSD Score [ Time Frame: 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.
3. Change in Clinical Global Impression Severity (CGI-S) Score [ Time Frame: 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.
4. Change in Dehydroepiandrosterone Sulfate (DHEA-S) [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks ]
   DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks
5. Change in Salivary Cortisol (First 6 Participants) [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks ]
6. Change in Salivary Cortisol (Last 6 Participants) [ Time Frame: 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.
7. Change in Serum Glucose [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks ]
8. Number of Other Adverse Events [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Wisconsin

Catherine Johnson

Madison, Wisconsin, United States, 53711

Wm. S. Middleton VA Hospital

Madison, Wisconsin, United States, 53711

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

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

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00204737
• Other Study ID Numbers: H-2004-0039
• First Posted: September 20, 2005
• Results First Posted: May 6, 2020
• Last Update Posted: May 6, 2020
• Last Verified: April 2020

• 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

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Prednisone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents