Short Course Glucocorticoid Treatment for PTSD

NCT00204737 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: H-2004-0039
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in Hamilton Depression Rating Scale (HAM-D)

  baseline, 2 weeks, 6 weeks, 12 weeks

• Change in PCL-PTSD Score

  baseline, 2 weeks, 6 weeks, 12 weeks

• Change in Clinical Global Impression Severity (CGI-S) Score

  baseline, 2 weeks, 6 weeks, 12 weeks

• Change in Dehydroepiandrosterone Sulfate (DHEA-S)

  Baseline, 2 weeks, 6 weeks, and 12 weeks

• Change in Salivary Cortisol (First 6 Participants)

  Baseline, 2 weeks, 6 weeks, and 12 weeks

Study Arms (2)

Prednisone

ACTIVE COMPARATOR

Prednisone 20mg daily x 2 weeks

Drug: prednisone

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

prednisone DRUG

20mg x 2 weeks

Prednisone

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (2)

Catherine Johnson

Madison, Wisconsin, 53711, United States

Location

Wm. S. Middleton VA Hospital

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Catherine Johnson
• Organization: University of Wisconsin - Madison

catherine.johnson2@va.gov

608-280-7084

Study Officials

• Catherine D. Johnson, PharmD, MS, BCPP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 6, 2020
• Results First Posted: May 6, 2020

Record last verified: 2020-04

Locations

US (2)