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Completed

NCT Number: NCT00204737

Short Course Glucocorticoid Treatment for 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

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Catherine Johnson, Madison, Wisconsin, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

20mg x 2 weeks

Placebo

Drug

placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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